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This Subcontract opportunity from Department Of Health And Human Services was posted on August 20, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Regulatory and Clinical Validation Support

Closed
Federal

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This subcontract opportunity with the Advanced Research Projects Agency for Health under the Department of Health and Human Services focuses on providing regulatory and clinical validation support. The selected provider will be responsible for developing regulatory strategies, performing gap analyses, creating test protocols, and offering guidance for FDA submissions specifically for novel diagnostic tools utilized in drug quality assurance. The solicitation was posted on August 20, 2026, with a response deadline of September 4, 2026. Classified under NAICS code 541690, the performance of this contract is centered in the 20005 zip code area.

General Info

ARPA-H subcontract for regulatory and clinical validation support for novel diagnostic tools.

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

DC, 20005, USA

Set-Aside

NONE

Documents

This scope was carved out of ARPA-H-SN-26-160.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and SupplieS (FASTPASS) Proposers' Day

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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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
Office AddressN/A
ContactsNo contact information available

Full Description

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Provide regulatory strategy, gap analysis, test protocol development, and FDA submission guidance for novel diagnostic tools used in drug quality assurance.

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