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Regulatory Affairs Support (IND/NDA)

Active

Federal

Response Deadline12/18/2026, 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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This subcontract for Regulatory Affairs Support focuses on managing the regulatory submission process for prime contractors within NIH/NICHD BPCA programs. The selected provider will be responsible for preparing and submitting Investigational New Drug and New Drug Applications, coordinating all necessary communications with FDA review divisions, and revising Clinical Study Reports. The primary deliverables include completed IND/NDA submissions and the successful processing of approved amendments. Qualified candidates must possess specialized experience in Phase 1, 2, and 3 pediatric drug development and demonstrate a thorough understanding of EMA guidelines. This opportunity is associated with NAICS code 541611 and falls under the jurisdiction of the Department of Health and Human Services. Responses are due by December 18, 2026.

General Info

Regulatory support for NIH/NICHD BPCA programs managing FDA IND/NDA submissions by December 18, 2026.

Agency

Department Of Health And Human Services → National Institutes Of Health Nichd

NAICS

541611 - Administrative Management and General Management Consulting Services

Place of Performance

MD, USA

Set-Aside

NONE

Documents

This scope was carved out of 75N94026R00008.

The full solicitation package (4 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Best Pharmaceuticals for Children Act Data Coordination Center

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Timeline

PostedNov 3

subcontract

Response DeadlineDec 18

Submission deadline

Response Deadline

12/18/2026, 09:00:00 PM UTCin about 1 month

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Nichd

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Nichd

Office AddressN/A

ContactsNo contact information available

Full Description

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Manages the regulatory submission process for prime contractors on NIH/NICHD BPCA programs. Prepares and submits Investigational New Drug (IND) and New Drug Applications (NDA), coordinates communications with FDA review divisions, and revises Clinical Study Reports (CSRs). Requires experience with Phase 1, 2, and 3 pediatric drug development and EMA guidelines. Delivers completed IND/NDA submissions and approved amendments.

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