Regulatory Strategy and Submissions 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 for the Regulatory Strategy and Submissions Support project to develop regulatory pathways and prepare necessary submissions, such as IND, 510(k), and NDA, to secure FDA approval for medical products developed under the grant. This opportunity is designated as a Total Small Business Set-Aside under the SBIR/STTR mandate, requiring the contractor to have fewer than 500 employees. The solicitation is categorized under NAICS code 541690 and was posted on May 28, 2026. Interested parties must submit their responses by the deadline of April 6, 2027. Further details regarding this requirement can be found through the SBIR portal.
General Info
Agency
NAICS
Place of Performance
Not specifiedSet-Aside
Documents
This scope was carved out of PA-27-102.
The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.
NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Optional)
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