Regulatory Strategy and IND Enabling Support

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.