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CMC Regulatory Support

Active
Federal

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 requires the preparation and submission of Chemistry, Manufacturing, and Controls (CMC) sections for Biologics License Applications (BLAs) focused on influenza vaccines. This includes developing and finalizing process validation protocols, stability study designs, and comprehensive quality control documentation to meet regulatory standards for vaccine approval. The work demands precise adherence to FDA guidelines and the ability to coordinate technical data across manufacturing, testing, and regulatory teams to ensure timely and compliant submissions. The contract is classified as a subcontract under NAICS code 541611 and is issued by the Department of Health and Human Services through Barda - ASPR / DAAPPO / Barda DCMA. Performance is to be carried out in Washington, DC, with a posting date of July 30, 2026, and a hard deadline for responses on August 15, 2026. All deliverables must be structured to support the regulatory pathway for influenza vaccines, emphasizing scientific rigor, operational consistency, and compliance with current good manufacturing practices.

General Info

Prepare and submit CMC documentation for influenza vaccine BLAs per FDA guidelines in Washington, DC by August 15, 2026.

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

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Timeline

Posted

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Response Deadline

Submission deadline

Response Deadline

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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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Prepare and submit CMC sections of BLAs, including process validation, stability protocols, and quality control documentation for influenza vaccines.

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