Regulatory Affairs and Submission Support

This contract involves providing specialized support in regulatory affairs, specifically focusing on the preparation and maintenance of critical regulatory documentation required for FDA submissions. Key responsibilities include managing Drug Master Files (DMFs), compiling annual reports, and overseeing change control processes to ensure compliance with regulatory standards. The scope reflects a need for expertise in regulatory compliance and documentation management to facilitate seamless interactions with the FDA. The contract is a subcontract under the Nac Federal Supply Schedule managed by the Department of Veterans Affairs. It falls under the NAICS code 541611, which pertains to administrative management and general management consulting services. Although specific details regarding the place of performance and points of contact are not provided, the solicitation was posted on May 6, 2026. This engagement supports federal regulatory requirements and helps maintain up-to-date submission documents critical for ongoing product approvals and regulatory compliance.