Regulatory Affairs and Compliance Support

The contract titled Regulatory Affairs and Compliance Support is a small business set-aside subcontract under the SBA program, aimed at providing specialized regulatory services to support FDA and VA Federal Supply Schedule compliance. The work involves the preparation, maintenance, and submission of regulatory documentation including Drug Master Files and other required compliance materials essential for adhering to federal regulatory standards. The North American Industry Classification System code 541611 indicates that the services fall under Administrative Management and General Management Consulting Services, emphasizing strategic regulatory guidance and documentation management rather than direct manufacturing or clinical activities. This subcontract is affiliated with the Department of Veterans Affairs through its National Academy of Medicine Federal Supply Schedule 36F797, focusing on ensuring that products and processes meet the stringent requirements for inclusion in VA procurement channels. The contract was posted on May 6, 2026, and while no specific performance location or point of contact is listed, the scope is clearly defined around sustaining regulatory integrity and continuous compliance with federal agencies. The emphasis on DMFs and FDA-aligned submissions underscores the technical nature of the work, requiring expertise in global regulatory frameworks, documentation lifecycle management, and the unique regulatory expectations of the VA FSS program.