Regulatory Compliance and Quality Assurance Support

The contract entails providing support services focused on ensuring FDA cGMP compliance, overseeing quality control documentation, and facilitating regulatory reporting related to the manufacturing and delivery of TheraSphere Y-90 microspheres. It is structured as a subcontract under the Department of Veterans Affairs, specifically through the 247-NETWORK Contract Office 7 (36C247). The contract requires expertise in maintaining strict adherence to regulatory standards within the pharmaceutical manufacturing environment, particularly concerning a specialized radiopharmaceutical product. Performance under this contract will take place in Charleston, with a primary focus on regulatory compliance and quality assurance activities that uphold the integrity and safety of the microsphere production and delivery processes. The contract operates under NAICS code 541611, which typically covers administrative management and general management consulting services, suggesting an emphasis on regulatory consulting and compliance support rather than direct manufacturing. This initiative supports the VA’s goal of maintaining high-quality healthcare products for veterans while meeting all federal regulatory obligations.