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Program Management and Regulatory Affairs

Active

Federal

Response Deadline07/30/2026, 09:00:00 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 contract entails comprehensive program management and regulatory affairs support for a drug-device combination product, focusing on end-to-end oversight of critical development and compliance activities. This includes managing regulatory submissions to health authorities, conducting human factors studies to ensure safe and effective user interaction, validating process performance qualification (PPQ) batches to confirm manufacturing consistency, and fulfilling all post-market licensing commitments required by regulatory agencies. The scope demands deep expertise in both pharmaceutical and medical device regulations, with an integrated approach to aligning clinical, quality, and technical documentation across global standards. The work is governed under a subcontract agreement linked to the Department of Health and Human Services via Barda - Aspr / Daappo / Barda Dcma, with performance centered in Washington, DC, at ZIP code 20024. The solicitation was posted on July 2, 2026, and responses are due by July 30, 2026, under the NAICS code 541611 for management consulting services. The contractor is expected to deliver coordinated, high-quality regulatory strategy and execution in a tightly regulated environment, ensuring timely approvals and sustained compliance throughout the product lifecycle.

General Info

Regulatory and program management for drug-device product with global compliance, human factors, PPQ, and post-market duties in Washington, DC.

Agency

Department Of Health And Human Services → Barda - Aspr / Daappo / Barda DcmaView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

Washington, DC, 20024, USA

Set-Aside

NONE

Documents

(0)

No documents available

AI Contract Breakdown

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Timeline

PostedJul 2

subcontract

Response DeadlineJul 30

Submission deadline

Response Deadline

07/30/2026, 09:00:00 PM UTCin 4 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma

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Office AddressN/A

ContactsNo contact information available

Full Description

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End-to-end oversight of regulatory submissions, human factors studies, PPQ, and post-market licensing commitments for a drug-device combination product.

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