Regulatory Strategy and Submission Support

The contract seeks a subcontractor to develop a comprehensive regulatory strategy and prepare necessary submissions for FDA approval of an analgesic medical device, targeting pathways such as IND, NDA, BLA, IDE, 510(k), or PMA depending on the device classification and intended use. The work must include strategic alignment with Department of Defense acquisition processes to ensure compatibility with military healthcare procurement protocols and timelines. The contractor is responsible for navigating complex regulatory requirements, coordinating with FDA centers as appropriate, and ensuring all documentation meets both clinical and compliance standards required for market authorization in the U.S. The project is focused on a device to alleviate pain, with the place of performance designated as Frederick, Maryland, at a ZIP code of 21702. The solicitation is classified under NAICS code 541690, which corresponds to other scientific and technical consulting services, indicating the work is professional and high-level in nature. The contract is a subcontract under the Defense Health Agency, part of the Department of Defense, with a response deadline of July 30, 2026, at 5:00 PM Eastern Time. The work must be completed with full awareness of DoD’s operational needs, including potential use in combat or field medical environments, and must support integration into defense healthcare systems once approved.