Regulatory Affairs and Submission Support

The contract under the title Regulatory Affairs and Submission Support involves the preparation and ongoing maintenance of critical regulatory documentation required for FDA submissions, including Drug Master Files, annual reports, and change control submissions. This work is essential to ensure compliance with federal regulatory standards and to support timely and accurate submissions throughout the product lifecycle. The contractor will be responsible for managing complex regulatory processes, updating documentation in response to evolving requirements, and coordinating with internal and external stakeholders to maintain the integrity and completeness of submission packages. This subcontract is categorized under NAICS code 541611 and is associated with the Department of Veterans Affairs through the Nac Federal Supply Schedule. The opportunity was posted on May 6, 2026, and is intended to support federal regulatory compliance activities without a specific set-aside designation. While the exact location of performance is unspecified, the scope of work requires expert knowledge of FDA regulatory frameworks and a high degree of precision in documentation management to meet the agency’s stringent submission standards. The contract will serve the Department of Veterans Affairs by ensuring its drug products remain in full regulatory compliance and are eligible for continued market access.