FDA/NIH Regulatory Affairs Consulting

This subcontract opportunity with the Department of Health and Human Services focuses on providing expert regulatory affairs consulting for prime contractors working on innovation projects for the NIH, CDC, and FDA. The selected provider will be responsible for developing regulatory strategies, creating compliance roadmaps, and preparing critical documentation, including 510(k) submissions, PMA applications, and Investigational Device Exemptions using specialized submission software. A deep expertise in FDA CFR is required to ensure all delivery packages meet strict federal standards. The contract is designated as a total small business set-aside under NAICS code 541611, specifically catering to firms with fewer than 500 employees in alignment with SBIR/STTR mandates. Interested parties must submit their responses by April 6, 2027, following the posting date of May 28, 2026.