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Regulatory Strategy and Submission Consulting

Active

SBIR / STTR

Response Deadline04/06/2027, 04:00:00 AM 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 Regulatory Strategy and Submission Consulting supports prime contractors receiving NIH SBIR/STTR grants by providing expert regulatory analysis and submission preparation. The scope of work includes developing regulatory strategies, managing clinical trial filings, and preparing 510(k) or PMA submissions to ensure full compliance with FDA and EMA standards. The selected provider must possess deep expertise in medical device and drug approval pathways to deliver a formal regulatory roadmap and completed submission packages. The opportunity is issued by the Department of Health and Human Services and is designated as a Total Small Business Set-Aside for firms with fewer than 500 employees. It falls under NAICS code 541611, with a response deadline of April 6, 2027.

General Info

HHS small business subcontract for regulatory strategy and submission consulting, deadline April 6, 2027.

Agency

Department of Health and Human Services

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

Not specified

Set-Aside

SBA

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.

View the prime solicitation

SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)

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Timeline

PostedMay 28

subcontract

Response DeadlineApr 6

Submission deadline

Response Deadline

04/06/2027, 04:00:00 AM UTCin 5 months

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Organization & Contact Information

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AgencyDepartment of Health and Human Services

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment of Health and Human Services

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs regulatory analysis and prepares submissions for prime contractors receiving NIH SBIR/STTR grants. Develops regulatory strategies, prepares 510(k) or PMA submissions, and manages clinical trial regulatory filings to ensure compliance with FDA/EMA standards. Requires deep expertise in medical device and drug approval pathways. Delivers completed regulatory submission packages and a formal regulatory roadmap.

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