Regulatory Support for IND and IDE Submissions

This small business set-aside subcontract, titled Regulatory Support for IND and IDE Submissions, provides specialized regulatory affairs expertise for prime contractors working on NIH/NHGRI projects. The scope of work focuses on managing Investigational New Drug and Investigational Device Exemption submissions, providing project oversight for vector management, and ensuring strict adherence to FDA regulatory guidelines. Key deliverables include completed submission packages and detailed regulatory compliance reports. The contract is managed under the Department of Health and Human Services for the National Institutes of Health Olao, with performance based in Bethesda. Due to the nature of the work, the execution of a Business Associate Agreement is required to maintain HIPAA compliance. Interested parties should note the response deadline of November 13, 2026, and the classification under NAICS code 541611.