This Government Contract opportunity from Department Of Health And Human Services was posted on April 23, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Regulatory Affairs & FDA Submissions Support

Closed

Federal

Submission Closed06/10/2026, 08:30:00 PM UTC

Contract Overview

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

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NAICS: 541611

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AI Contract Overview

The contract titled Regulatory Affairs & FDA Submissions Support is a subcontract issued under a Total Small Business Set-Aside by the National Institutes of Health, part of the Department of Health and Human Services, with a NAICS code of 541611. It mandates the preparation and submission of critical regulatory documentation for FDA interactions, including pre-IND meeting packages, briefing books, and formal responses to FDA inquiries, ensuring compliance with federal regulatory requirements. The work is essential to advancing product development through timely and accurate regulatory communications with the agency. The solicitation was posted on April 23, 2026, with a firm deadline for responses on June 10, 2026, at 8:30 PM Eastern Time. As a small business set-aside, only eligible small business concerns may submit proposals. The place of performance and point of contact details are not specified, indicating the work may be performed remotely or at the contractor’s location. All submissions must align with the Federal Acquisition Regulation and demonstrate capability in navigating complex FDA regulatory pathways.