Chemistry, Manufacturing, and Controls (CMC) Development

The contract involves comprehensive Chemistry, Manufacturing, and Controls (CMC) development for an analgesic product, encompassing formulation development, process validation including Installation Qualification, Operational Qualification, and Performance Qualification, as well as scale-up activities necessary to support regulatory submissions to the FDA such as IND, NDA, or BLA. All activities are designed to ensure compliance with regulatory standards and to enable successful approval of the product through robust, scalable, and validated manufacturing processes. The work is to be performed in Frederick, Maryland, under a subcontract awarded by the Defense Health Agency, part of the Department of Defense, with a NAICS code of 325412 indicating pharmaceutical preparation manufacturing. The opportunity was posted on June 29, 2026, and responses are due by July 30, 2026, at 5:00 PM EST. The contract requires execution of technical activities aligned with FDA expectations for CMC documentation, with no set-aside provisions specified, and all deliverables must support the transition from development to commercial-scale manufacturing under regulatory oversight.