Regulatory Strategy and Submission Support
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The Department of Health and Human Services is seeking a subcontractor to provide specialized regulatory consulting and support for FDA submissions. The scope of work includes the preparation of Investigational New Drug, Investigational Device Exemption, Biologics License Application, or 510(k) filings, as well as managing interactions with the agency. This opportunity is designated as a Total Small Business Set-Aside under the SBIR/STTR mandate for companies with fewer than 500 employees, falling under NAICS code 541690. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.
General Info
Agency
NAICS
Place of Performance
Not specifiedSet-Aside
Documents
This scope was carved out of PAR-27-098.
The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.
SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)
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