Regulatory Compliance and FDA Liaison Services

The contract requires comprehensive regulatory support to ensure Paxlovid supply chains comply with FDA requirements under the Federal Food, Drug, and Cosmetic Act and Title 21 of the Code of Federal Regulations. This includes preparing and reviewing regulatory documentation, validating labeling accuracy, and coordinating closely with Defense Logistics Agency product specialists to maintain alignment with federal standards. The work must be executed with strict adherence to FDA protocols to safeguard product integrity, ensure proper patient labeling, and facilitate uninterrupted supply availability under DOD oversight. This subcontract is issued under NAICS code 541611 and is managed by the Medical Supply Chain Pharm FSA within the Department of Defense. The place of performance is designated as FPO with ZIP code 96694-1500, indicating operations will be conducted through military postal channels. Although no specific point of contact is listed, the response deadline is May 18, 2026, and the solicitation was posted on May 10, 2026, via the DIBBS procurement platform. The scope demands expert regulatory knowledge and seamless interagency coordination to meet DOD supply continuity goals while maintaining full FDA compliance.