Regulatory Strategy & FDA Submission Support

The contract seeks the development of a regulatory pathway strategy and comprehensive support for FDA submissions related to an autoinjector classified as a combination product. The work involves designing and executing a regulatory plan that aligns with FDA expectations for combination products, ensuring all necessary documentation, data, and procedural requirements are met for successful clearance or approval. Activities will include preparing and submitting key regulatory documents, coordinating with FDA review teams, and providing strategic guidance throughout the pre-submission and submission phases to mitigate risks and accelerate timelines. This subcontract is issued under the Department of Defense's W6QK Acc-Apg agency, with performance required at a location in Gunpowder, Maryland, 21010. The opportunity was posted on July 16, 2026, with a response deadline of August 7, 2026, and falls under NAICS code 541611, which categorizes it as management consulting services. The contract is not reserved for any specific small business set-aside and requires a qualified entity with proven expertise in regulatory affairs for combination products, particularly those involving drug-device systems like autoinjectors. The successful bidder must demonstrate a track record in navigating the FDA’s complex regulatory framework and possess the technical capability to deliver high-quality submission packages under strict timelines.