Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Normalized: nelson labs portal essf frozen tissue samples additional questions
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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2026-02-24 04:31:44.535234+00:00
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description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
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Separation Confidence
How distinct this entity is from others. Higher means no close matches existed when it was created. Lower means a near-match was rejected just below the 80% threshold — worth reviewing.
Moderate — a somewhat similar entity exists
97%
Avg Match Confidence
The average confidence score across all active source mappings. Shows overall quality of linkage between source records and this canonical entity.
Strong source linkage
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Source Record
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
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2026-02-24
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2026-04-09T14:00:42.172461+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
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Justin Wray
modified_by
Justin Wray
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—
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-01T02:08:42.790112+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
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Justin Wray
modified_by
Justin Wray
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
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brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-31T02:07:58.020249+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
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—
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-27T02:07:53.245615+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
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—
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| moreland_contracts | c/SQIUMxpe0p8g | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-26T02:08:48.940104+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | s1x/pXU99zj/og | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-06T00:06:30.424805+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | lGCFrF61uaOz1g | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-06T02:06:52.386438+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | /Wi27pxlJXWQMw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-05T00:05:52.216710+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
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Justin Wray
modified_by
Mark Murphy
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—
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Source Record
bronze_moreland_contracts_ma_project_contracts
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T12:05:28.057113+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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| moreland_contracts | khpB3bg8j0UUlg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-04T06:08:31.193809+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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| moreland_contracts | ZynUlU9rhe4n4A | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-03T00:06:18.207564+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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| moreland_contracts | c75iShHdHYL1sQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T18:07:18.315067+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | D056xJCV/+rHSA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T12:05:25.196825+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | AIwQS5N9lsfsIA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-04T00:07:13.872058+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | qhK+CDed5ejr7Q | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-05T06:06:30.342956+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | cm031tH5Wtc6gA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-06T12:06:28.054260+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | Cz89Ep5WZ7b9UQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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|
Source Record
bronze_moreland_contracts_ma_project_contracts
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-19T21:23:39.455764+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-28T02:08:13.084408+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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Source Record
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-07T02:08:10.274818+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-09T02:06:40.169413+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | /P1AHsMZhcAMGA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-10T02:07:41.580280+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | 1O/TnNGhrg+5Gw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-11T02:06:43.353785+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | 9bPoLX1Lp4A1Yw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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200.0
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-11T02:06:46.022136+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | Rga56AlgQ+UHag | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_name
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-12T02:06:13.400132+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | EVDgMEzJd7LD8w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-12T02:06:10.949995+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-13T02:07:12.691167+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-13T02:07:15.061235+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
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2026-03-11T16:40:08+00:00
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Justin Wray
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Justin Wray
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—
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-14T02:07:08.092928+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
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2026-03-11T16:40:08+00:00
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Justin Wray
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Justin Wray
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—
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-14T02:07:05.137798+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | jFJSFKP9HGv3nA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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bronze_moreland_contracts_ma_project_contracts
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file_name
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-15T02:06:56.363466+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | tHcp/2/EkW/S8w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-15T02:06:53.832543+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | OrtTLD9H5jSNPg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-16T02:07:14.343441+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | eU4Yb4ycYeL0Eg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-16T02:07:16.896704+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | qYWpKdjmTVEq0g | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-17T02:06:50.274766+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
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2026-03-11T16:40:08+00:00
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Justin Wray
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Justin Wray
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
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22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-17T02:06:47.582773+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-18T02:07:09.094042+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-18T02:07:06.256323+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | nB0ZHPT0hV/M1A | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-19T02:06:06.767910+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | iDF2/w6Ucll+3w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-19T02:06:08.746243+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | mtWss2srpNeW4A | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-05T02:07:09.098231+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | Paq5qvbDC1QJPw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
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22.0
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T02:07:23.919659+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | +yGMhR5zMbZTFQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T06:06:17.967046+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | tPN73Dovsbd5Jg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-26T00:07:08.029797+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | FWJ4fyoBTU0vrg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-26T02:07:11.717051+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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| moreland_contracts | hJejE43Ajebz3Q | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-25T06:07:16.322200+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | RAZN70Dd1MqiSg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-25T12:06:49.937373+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | xCANN6uC9Rrd+w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-25T12:06:53.766044+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | qxOB5NPXWVa0SQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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22.0
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T12:06:43.857975+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | 4PE7arYYybjZyg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-19T06:07:17.564053+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | iLA8Ad3HGufC0Q | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-21T02:07:19.823370+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | QEbwLdrGjbiFYw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-21T06:07:02.082897+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
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Justin Wray
modified_by
Mark Murphy
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—
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T06:06:21.283767+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
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2026-02-12T14:48:58+00:00
created_by
Justin Wray
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Mark Murphy
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—
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-05T06:06:27.528053+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | PkxBSC8PGnOqfw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-19T15:18:41.896485+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
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Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | FjjoIfjEGn88fg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-20T02:06:57.924207+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | 8k1khUVieCXC/w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-21T02:07:43.155855+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | 4MGizeQpJ0Nk5A | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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4400.0
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-24T02:07:34.544107+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | 5c7O6RreT5n30g | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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—
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Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-25T02:08:29.449211+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | EYKYpRq+Ba10Mg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-28T02:08:10.174249+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-29T02:06:59.141170+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | AFkCc+zck9pieg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-06T02:07:28.720389+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
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Justin Wray
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Justin Wray
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—
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| moreland_contracts | vCYrqXDNp/Hqqg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-09T14:00:44.920026+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | GjifY1Brt07RiQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-08T02:07:39.505070+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | pVs1H6U2v1sKjg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-05T02:07:05.763885+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | xEjeGcp9z2XH+w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-04T02:08:00.675740+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | bgww7jjmAJGhqg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
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22.0
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-02T02:07:39.993112+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | scjTq/6HiaXeqA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-01T02:08:45.841963+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
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Justin Wray
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Justin Wray
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-30T02:08:25.298151+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | XtsSXIgas47DqA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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5a0da33700cff3a0b1eaea01b02afbae
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-30T02:08:22.435068+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | YqCStZW7QhSvhg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-27T02:07:49.405249+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | 23eA0kSQoSAqiQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-26T02:08:45.589906+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | n9iHb9YWURPgMw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-24T02:07:29.992300+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | f+G6M58Xd4orvQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-22T02:06:55.062496+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | 798ZbbYZo5mYJQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-22T02:06:58.240575+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | T4TBe0VmIxO4IA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-06T00:06:32.977628+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | MGeRUfanHFTkKQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/Shared%20Documents/Internal%20-%20Business%20Development/Sotera/Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-06T06:06:18.782091+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | QLvcXfHyUC12xw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-06T06:06:21.500581+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | SPRKErJ4915yrQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T18:07:21.973734+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | B2cgjb486rlBGA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
|
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Source Record
bronze_moreland_contracts_ma_project_contracts
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-04T06:08:23.645348+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | dQ6K2WyUa7geZw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
|
|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-26T18:07:04.422285+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | NUrI86YgGVW8hw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T02:07:26.681471+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | ZBpbsywC7k0pFw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
|
|
Source Record
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file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-04T02:07:33.747934+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | xf8L21Bz76tjzg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
|
|
Source Record
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-02T18:06:29.754165+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | EmIhaHBcvuF2TA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
|
|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-02T18:06:32.879713+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
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2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
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—
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| moreland_contracts | xJEegTUzNS6uEw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T18:07:11.988789+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | c7V6PCR3IsgKTw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T00:06:39.286165+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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| moreland_contracts | qRHB5knCf1ipVw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-23T00:07:58.932926+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | xrvfpxTIkrhsQg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-23T02:07:18.277784+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | VjFmiBhdkNKuzg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-20T18:06:24.849575+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | wYh1ec81QW6lLw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-23T18:07:39.229872+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | Y2OMmBfVxkMEaA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-02T17:50:30.298178+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | E5Xh+9t3GDslkA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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|
Source Record
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/Shared%20Documents/Internal%20-%20Business%20Development/Sotera/Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-03T00:06:14.631196+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | h5scu3mygZaK3Q | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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5a0da33700cff3a0b1eaea01b02afbae
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-05T12:07:14.649017+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
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4400.0
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-25T02:08:33.489154+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | gbuc06iB8xH+XA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-29T02:07:02.076198+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | SKIpD2t9voBx0g | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-08T21:09:43.858230+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | FlHYOKzDacNqKQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-09T02:06:42.629757+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | 6TLQ/rklLVWc/g | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-08T21:09:46.605354+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | sbaKfwfJYP/pSA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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|
Source Record
bronze_moreland_contracts_ma_project_contracts
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-03T02:07:16.983106+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | 6qiwHreoSxh9OA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
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file_name
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-04T02:07:36.447635+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | qbxp/N6a/j3uhw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-04T12:06:59.960874+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | o4cLDOhbf5c8uA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-02T17:50:19.823871+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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| moreland_contracts | Dj3JfZIfn5lyIA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-26T12:07:47.636034+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
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Mark Murphy
_dlt_meta
—
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-26T12:07:43.202188+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | 8LVm0hiW9qTnnQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-25T18:07:35.664427+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | Ph/R6uw56ieGXg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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hourly_rate
200.0
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T06:06:56.198007+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | pSlq7fXxfqlbvw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_name
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T12:06:46.904319+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | Zk/gonDEKvcIGQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-26T00:07:11.951427+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | t4uR2YJlLg8Kog | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-26T02:07:08.450186+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-25T06:07:13.204982+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T00:06:36.783851+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | vFOAG3FVTXOyRQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-21T18:06:55.183250+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | jaFzsycl904b+A | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-19T03:12:58.347918+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | o0jXXKMVly8kDQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
4400.0
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-21T00:07:50.369790+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | DMbC8Jb9HkO2+w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-22T00:06:26.454369+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | Ia9y6NFYXxEFNA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-20T00:06:02.020213+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | V6ZLu1xIUXMyUg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-20T02:07:46.091712+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | luKU+V2prMjR7w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-19T18:07:13.880661+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-22T02:06:56.290977+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | 4O4TvEk+w1DFLg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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5a0da33700cff3a0b1eaea01b02afbae
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-04T12:06:56.934951+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | e5CR9Oc4qnr/3g | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-05T02:06:48.505818+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | zca0OccxK5IK2w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_hash
5a0da33700cff3a0b1eaea01b02afbae
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-20T02:06:55.146815+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | FHF6KLy5wNpmzw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
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file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-23T02:07:37.391188+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | U9Yx0Fu+xJ4CDg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/Shared%20Documents/Internal%20-%20Business%20Development/Sotera/Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-06T02:07:25.747301+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | wiK8oU58SUl7Ng | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
bronze_moreland_contracts_ma_project_contracts
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-08T02:07:36.299177+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | UezqKh9g/mj14A | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-10T02:07:45.036351+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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time_and_materials
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200.0
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total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-07T02:08:05.372557+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
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2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-04T02:07:57.592398+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
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2026-02-23T20:26:37+00:00
created_by
Justin Wray
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Justin Wray
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—
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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16.0
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-04-03T02:07:13.902897+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
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Justin Wray
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—
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| moreland_contracts | 5Wc/ZRQV0Pso1w | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-04-02T02:07:44.084746+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | ktNefcBILQ8uUQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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hourly_rate
200.0
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-31T02:08:01.046873+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | KaZquuF6QnGzdA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
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2026-02-24
extracted_at
2026-03-23T02:07:41.189780+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | 8Dgw+bhohFfXqw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-21T02:07:47.005036+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | 3EQanxK/SMnlRg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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—
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Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
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2026-02-24
extracted_at
2026-03-19T15:18:39.058373+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | Bf8VBOmnoeZ3GA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/_layouts/15/Doc.aspx?sourcedoc=%7B8E7934C1-C6D2-4603-B2BB-66A7E5941615%7D&file=Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx&action=default&mobileredirect=true
company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-19T21:23:42.697986+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-03-11T16:40:08+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | 44O22YcVSQ8lGw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-06T02:06:55.016892+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | Yy/Fz8flCiMzzA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-06T12:06:30.473380+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | 7xdBeyAJCpxraQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-04T18:07:26.535080+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | Lb5AE5V/RzvbGQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-04T00:07:10.848041+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | pWXRadKNrrHQig | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-04T18:07:23.301624+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | vID/CGugIkoMjg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-02T17:50:16.848651+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | kQAtVMsDtRAGQw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-02T17:50:33.407135+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | ooNWOjVEVl1y+Q | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
|
|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/Shared%20Documents/Internal%20-%20Business%20Development/Sotera/Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-26T18:06:59.290482+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | /1UiTEkU+u2Y8g | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-25T18:07:38.801669+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | tqoSdbrNaNqHLw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-25T00:06:23.039451+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | 7nD9Wn4z1Z85eg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-25T02:06:41.488346+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | XZwgXxFqF5UPfg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T06:06:52.242701+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | vTPUyzCTQnmRuA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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Source Record
bronze_moreland_contracts_ma_project_contracts
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-25T00:06:25.996362+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | VXPVZYSMqZtaJQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-23T12:06:52.356240+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | aalwLqhr7eftjg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-23T06:08:14.653700+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | LQqY6Km346SxyQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-19T03:10:52.816938+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
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Mark Murphy
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—
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Source Record
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-20T12:06:56.651844+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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| moreland_contracts | yjAwXz0PxR1jrw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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200.0
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22.0
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4400.0
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-22T06:06:03.682826+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
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| moreland_contracts | TYAv2LYKPce47Q | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-21T12:06:44.717858+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | jpnO8oz4xBXekw | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-22T12:06:42.458359+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | HuBau6XydkXNfg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-20T06:06:57.954154+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | eJk0DNPVFseCfQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-19T12:07:17.266374+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
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| moreland_contracts | QdrqGRJdlM2dmA | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
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file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T02:07:42.492807+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| moreland_contracts | 6cmK+dj2K1FGeQ | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
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372834df4e0635dd6faf93a37505a1f6
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.docx
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T02:07:45.567532+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
file_created_at
2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
_dlt_meta
—
|
|||||||
| moreland_contracts | ME0yCGLHOkETbg | Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions | 1.00 | exact | Active |
|
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|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples.pdf
file_path
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
22.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-25T02:06:38.497083+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
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2026-02-23T20:26:37+00:00
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Justin Wray
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Justin Wray
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—
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
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—
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Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-24T18:07:09.001216+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
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Justin Wray
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Justin Wray
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—
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Sotera Health LLC
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Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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estimated_hours
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total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-05T12:07:17.519469+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
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Mark Murphy
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Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-03-05T02:06:51.695638+00:00
raw_text_preview
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter ("Agreement") confirming our consulting services (the "Services") to assist Sotera Health LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety of healthcare by providing mission-critical services to the medical device, pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested enhancements to the eSSF to capture additional questions related to frozen tissue samples and bioburden testing for HCT/P industry segment submissions (Planview Card 2409555261). These updates will also require corresponding CRM updates to ensure proper mapping, data persistence, and reporting alignment. Moreland will design, implement, and test these enhancements in coordination with the Sotera project team, following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and bioburden testing fields as outlined in the provided specification documentation (Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
New Section: “Health Services Act Details” (conditional on Industry Segment = HCT/P’s)
Display a new section after the Test(s) section when Industry Segment = Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s).
Question 1: “What section of the Health Service Act is the sponsor following?” (multi-select, at least one required)
Section 351 P
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2026-02-12T14:47:12+00:00
file_modified_at
2026-02-12T14:48:58+00:00
created_by
Justin Wray
modified_by
Mark Murphy
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
16.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-03-05T00:05:47.771897+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products, as well as a validation enhancement to the Safety section.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
1960 CASE PKWY S TWINSBURG , OHIO 44087 o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-23T20:26:37+00:00
created_by
Justin Wray
modified_by
Justin Wray
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
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total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-21T18:06:58.234269+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-23T12:06:57.040008+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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Sotera Health LLC
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Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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20.0
total_fee_estimate
—
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Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
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2026-02-24
extracted_at
2026-02-20T12:06:59.525423+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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—
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Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-23T02:07:20.868531+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
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total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-22T06:06:06.888929+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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—
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
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brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-20T06:07:00.960150+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-23T00:08:03.290896+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
20.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-19T06:07:22.256543+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
20.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-23T18:07:42.911221+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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200.0
estimated_hours
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-22T00:06:29.650026+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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—
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Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
contract_type
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200.0
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-19T03:13:01.744758+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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—
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
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Sotera Health LLC
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Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-21T06:07:05.787475+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
20.0
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brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-19T03:10:56.267538+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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200.0
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-22T02:06:59.615545+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-22T12:06:46.257225+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
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200.0
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total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-21T02:07:23.228605+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
20.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-21T12:06:48.204850+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
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200.0
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brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-23T06:08:19.206914+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
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2026-02-12T14:50:56+00:00
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2026-02-12T14:50:56+00:00
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Justin Wray
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Justin Wray
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—
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Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
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total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-20T02:07:50.387383+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-12T14:50:56+00:00
created_by
Justin Wray
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Justin Wray
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—
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Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
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Sotera Health LLC
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Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
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Mitch Perkins
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200.0
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—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-19T12:07:20.513659+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-12T14:50:56+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
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| moreland_contracts | wZyOZrwhZ5B+Jw | Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions | 0.80 | fuzzy+embedding | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
file_path
https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/Shared%20Documents/Internal%20-%20Business%20Development/Sotera/Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
20.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-19T18:07:17.275399+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-12T14:50:56+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | MSVjAO9ymHOBuQ | Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions | 0.80 | fuzzy+embedding | Active |
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Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
file_path
https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/Shared%20Documents/Internal%20-%20Business%20Development/Sotera/Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
20.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing.
start_date
2026-02-24
extracted_at
2026-02-20T00:06:05.261218+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-12T14:50:56+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | lrT41epi2BlAcw | Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions | 0.80 | fuzzy+embedding | Active |
|
|
|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
file_path
https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/Shared%20Documents/Internal%20-%20Business%20Development/Sotera/Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
20.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-21T00:07:53.583730+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-12T14:50:56+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
|||||||
| moreland_contracts | Dj03wvWCRDigBw | Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions | 0.80 | fuzzy+embedding | Active |
|
|
|
Source Record
bronze_moreland_contracts_ma_project_contracts
file_hash
5a0da33700cff3a0b1eaea01b02afbae
file_name
Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
file_path
https://morelandpartners.sharepoint.com/sites/MorelandConnect-BusinessDevelopment/Shared%20Documents/Internal%20-%20Business%20Development/Sotera/Sotera_Health_-_Arrangement_Letter_-_eSSF_Frozen_Tissue_Samples_-_DRAFT.pdf
company
Sotera Health LLC
project_name
Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
contact_person
Mitch Perkins
contract_type
time_and_materials
hourly_rate
200.0
estimated_hours
20.0
total_fee_estimate
—
brief_project_description
Enhancements to the Nelson Labs Portal electronic Sample Submission Form (eSSF) to support frozen tissue sample submissions and bioburden testing for HCT/P products.
start_date
2026-02-24
extracted_at
2026-02-20T18:06:28.296251+00:00
raw_text_preview
1960 CASE PARKWAY SOUTH
TWINSBURG , OHIO 44087
February 12, 2026
Re: Nelson Labs Portal Enhancements: eSSF Frozen Tissue Samples Additional Questions
Dear Mitch:
MorelandConnect LLC ("Moreland") is pleased to provide this Arrangement Letter
("Agreement") confirming our consulting services (the "Services") to assist Sotera Health
LLC ("Sotera") with enhancements to the Nelson Labs Portal electronic Sample
Submission Form (eSSF) to support frozen tissue sample submissions and bioburden
testing for HCT/P products.
Background
Sotera Health Services is a fully integrated protector of global health, ensuring the safety
of healthcare by providing mission -critical services to the medical device,
pharmaceutical, tissue, and food industries.
As part of ongoing improvements to the Nelson Labs Portal, Sotera has requested
enhancements to the eSSF to capture additional questions related to frozen tissue
samples and bioburden testing for HCT/P industry segment submissions (Planview Card
2409555261 ). These updates will also require corresponding CRM updates to ensure
proper mapping, data persistence, and reporting alignment. Moreland will design,
implement, and test these enhancements in coordination with the Sotera project team,
following a similar process to the previous HCT/P FDA eSSF enhancement effort.
Project Scope and Approach
Project Scope
Moreland will update the eSSF to incorporate the new frozen tissue sample and
bioburden testing fields as outlined in the provided specification documentation
(Planview Card 2409555261, submitted by Kate Corr, January 23, 2026).
Enhancements include:
eSSF and CRM Enhancements
1. New Section: “Health Services Act Details” (conditional on Industry Segment =
HCT/P’s)
o Display a new section after the Test(s) section when Industry Segment =
Human Cells, Tissues, and Cellular and Tissue -Based Products (HCT/P’s).
1960 CASE PKWY S TWINSBURG , OHIO 44087 2. Question 1: “
file_created_at
2026-02-12T14:50:56+00:00
file_modified_at
2026-02-12T14:50:56+00:00
created_by
Justin Wray
modified_by
Justin Wray
_dlt_meta
—
|
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| quickbooks_make | 25664 | eSSF Frozen Tissue Samples | 0.80 | fuzzy+embedding | Active |
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|
|
Source Record
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2026-04-29 04:00:00+00:00
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22908
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Nelson Laboratories, LLC
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eSSF Frozen Tissue Samples
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