Regulatory Strategy and FDA Submission Support

The contract requires the development and execution of a comprehensive regulatory pathway to support FDA submission for at least one product by Phase III clinical trials, encompassing all necessary pre-submission activities, ongoing compliance measures, and the preparation of a complete regulatory dossier. The work must align with FDA expectations and guidelines, ensuring that all documentation, data packages, and communications are meticulously structured to facilitate a successful submission. The contractor is expected to navigate complex regulatory landscapes, engage proactively with the FDA through formal pre-submission meetings, and maintain rigorous quality control over all regulatory materials throughout the product development lifecycle. This subcontract is issued by the Advanced Research Projects Agency for Health under the U.S. Department of Health and Human Services, with a North American Industry Classification System code of 541618, indicating services in research and development in the social sciences and humanities, specifically tailored to biomedical regulatory strategy. The opportunity was posted on April 28, 2026, with a firm response deadline of May 28, 2026, at 5:00 PM. Performance location and point of contact details are not provided, and there is no set-aside designation specified. The contract aims to advance innovative health technologies through structured regulatory planning, emphasizing speed, compliance, and readiness for federal review.