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This Government Contract opportunity from Department Of Health And Human Services was posted on May 21, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Regulatory Consulting and FDA Submission Support

Closed
Federal

Contract Overview

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

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AI Contract Overview

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The contract involves providing strategic regulatory planning and submission support services specifically tailored for New Drug Application (NDA), supplemental New Drug Application (sNDA), or Biologics License Application (BLA) filings related to antifungal medical countermeasures. The focus is on guiding and assisting with the complex regulatory requirements necessary for successful FDA submissions in this specialized medical field. Issued by the Department of Health and Human Services under the BARDA division, the opportunity is classified under NAICS code 541611, which pertains to administrative management and general consulting services. It is structured as a subcontract, with the response deadline set for June 21, 2026. Performance location details are not specified, and there is no indication of set-aside status. The contract aims to leverage expert regulatory consulting to facilitate the development and approval of critical antifungal therapies intended for medical countermeasure use.

General Info

Strategic regulatory consulting for NDA, sNDA, BLA antifungal filings under BARDA, deadline June 21, 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

DC, USA

Set-Aside

NONE

Documents

This scope was carved out of RFI-MCM-TDRFI-BARDA-2026.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

RFI - Medical Countermeasures for the Treatment of Drug-Resistant Fungal Infections

AI Contract Breakdown

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No contract breakdown available.

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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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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Strategic regulatory planning and submission support for NDA, sNDA, or BLA filings related to antifungal medical countermeasures.

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