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Regulatory Affairs and Submissions 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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This contract involves providing comprehensive regulatory affairs and submissions support, specifically focused on preparing and submitting documentation to the FDA. Key tasks include handling Investigational New Drug (IND) and Investigational Medicinal Product Dossier (IMPD) applications, supporting Biologics License Applications (BLA), and responding to inquiries from regulatory agencies. The contract is structured as a subcontract under the NAICS code 541611, which pertains to administrative management and general management consulting services. Issued by the Department of Health and Human Services through the Barda - Aspr / Daappo / Barda Dcma office, the solicitation was posted on March 20, 2026, and responses are due by September 25, 2028. While specific location details and points of contact are not provided, the work is intended to support regulatory compliance efforts essential for advancing medical and biopharmaceutical developments through FDA oversight. This contract is crucial for ensuring that regulatory submissions are accurately prepared and timely, facilitating smooth interactions with the agency.

General Info

Provide FDA regulatory submissions support including IND, IMPD, BLA preparation and agency response.

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

DC, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

subcontract

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
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Prepare and submit regulatory documentation to FDA, including IND/IMPD applications, BLA support, and responses to agency inquiries.

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3 months ago

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