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Regulatory Consulting and Compliance Analysis

Active

Federal

Response Deadline01/22/2027, 10:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The Regulatory Consulting and Compliance Analysis subcontract, issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, seeks a partner to provide expert analysis on regulatory impact and ensure strict alignment with FDA standards for regulatory science projects. The selected provider will be responsible for drafting regulatory impact statements, ensuring compliance with the Paperwork Reduction Act, and delivering critical regulatory strategy documents, compliance reports, and impact analyses. This opportunity requires deep expertise in FDA regulatory pathways to support prime contractors effectively. Interested parties should note that the response deadline is January 22, 2027, and the work falls under NAICS code 541611.

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of FDABAA-27-00123.

The full solicitation package (4 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FY27 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

AI Contract Breakdown

Uniform Contract Format

No documents to break down

The breakdown needs solicitation documents. None were found from this contract's source.

Timeline

PostedOct 30

subcontract

Response DeadlineJan 22

Submission deadline

Response Deadline

01/22/2027, 10:00:00 PM UTCin 3 months

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressN/A

ContactsNo contact information available

Full Description

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Provides expert analysis on regulatory impact and ensures alignment with FDA standards for prime contractors on FDA regulatory science projects. Drafts regulatory impact statements and ensures Paperwork Reduction Act (PRA) compliance. Requires deep expertise in FDA regulatory pathways. Delivers regulatory strategy documents, compliance reports, and impact analyses.

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