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This Government Contract opportunity from Department Of Health And Human Services was posted on May 19, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Regulatory Strategy and IND Enabling Support

Closed
Federal

Contract Overview

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This subcontract involves providing regulatory consulting services to support the preparation of an Investigational New Drug (IND) application. The consulting will cover critical components such as Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical sections, ensuring alignment with FDA/CBER guidelines. The objective is to develop a comprehensive regulatory strategy that facilitates the submission and approval process for the IND. The contract is titled "Regulatory Strategy and IND Enabling Support" and falls under the NAICS code 541690. It is managed by the National Institutes of Health, part of the Department of Health and Human Services, with work to be performed in Bethesda, Maryland (zip code 20892). The solicitation was posted on May 19, 2026, with a response deadline of June 3, 2026. This opportunity is structured as a subcontract, emphasizing the need for specialized expertise in regulatory affairs to assist in meeting federal requirements for drug development.

General Info

Provide regulatory consulting for IND application, covering CMC, nonclinical, clinical sections to meet FDA guidelines.

Agency

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

NAICS

541690 - Other Scientific and Technical Consulting ServicesView NAICS

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

(0)

No documents 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 → National Institutes Of Health Olao
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health Olao
Office AddressN/A
ContactsNo contact information available

Full Description

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Regulatory consulting to support IND application preparation, including CMC, nonclinical, and clinical sections in alignment with FDA/CBER guidelines.