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Regulatory & GMP/GLP Compliance Consulting

Active

Federal

Response Deadline10/07/2026, 06:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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This subcontract for the Advanced Research Projects Agency for Health (ARPA-H) focuses on providing specialized regulatory and compliance consulting for prime contractors involved in COSMOS projects. The primary objective is to ensure that the development of microphysiological systems occurs under Good Manufacturing Practice and Good Laboratory Practice conditions to secure future FDA regulatory approval for reproducible disease models. The selected provider must possess extensive expertise in FDA regulatory standards specifically related to in vitro testing models. Key deliverables include the creation of regulatory compliance roadmaps and alignment reports to guide the project toward successful regulatory buy-in. The opportunity is categorized under NAICS code 541690, with a response deadline of October 7, 2026.

General Info

Regulatory consulting for ARPA-H COSMOS projects to ensure FDA compliance for disease models.

Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)View Agency

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

DC

Set-Aside

NONE

Documents

This scope was carved out of ARPA-H-SOL-26-165.

The full solicitation package (8 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

ARPA-H Comprehensive Organ System Modeling in Outer Space (COSMOS) Innovative Solutions Opening

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Timeline

PostedSep 16

subcontract

Response DeadlineOct 7

Submission deadline

Response Deadline

10/07/2026, 06:00:00 PM UTCin 21 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

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Office AddressN/A

ContactsNo contact information available

Full Description

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Provides regulatory expertise for prime contractors on ARPA-H COSMOS projects. Advises on the development of MPS under Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) conditions to ensure future FDA regulatory buy-in for reproducible disease models. Requires deep expertise in FDA regulatory standards for in vitro testing models. Delivers regulatory compliance roadmaps and alignment reports.

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