Regulatory Strategy and FDA Alignment Consulting

The contract seeks specialized consulting services to develop and implement a regulatory strategy aligned with FDA quality assurance standards, ensuring that system outputs are positioned for successful approval or adoption under applicable regulatory pathways. The work focuses on providing expert guidance to navigate the complexities of federal regulatory requirements, with particular emphasis on health technology systems undergoing evaluation by the Food and Drug Administration. The contractor must demonstrate a deep understanding of FDA processes, including validation, documentation, and compliance frameworks, to support the development of defensible, scalable, and FDA-ready solutions. This subcontract is issued by the Advanced Research Projects Agency for Health under the Department of Health and Human Services, with a place of performance in Washington DC, 20005. The opportunity is classified under NAICS code 541611 for management consulting services and is open for responses until August 20, 2026. While no specific set-aside designation is provided, the solicitation is structured to attract qualified entities capable of delivering strategic regulatory advisory services to federal health innovation initiatives. The contract aims to accelerate the translation of advanced health technologies into clinically adopted solutions by embedding regulatory compliance early and systematically into the development lifecycle.