Quality Assurance and Regulatory Compliance Support

The contract encompasses third-party validation services for SIR-Spheres, ensuring sterility, radioactivity levels, and full regulatory compliance with FDA and NRC requirements. This includes comprehensive batch testing protocols, meticulous documentation of all test results and procedures, and maintaining audit readiness to meet stringent federal standards. The provider is expected to operate under a quality assurance framework that supports consistent product safety and regulatory adherence throughout the manufacturing and distribution lifecycle. Execution of this subcontract falls under the NAICS code 541380, indicating scientific and technical consulting services, and is managed by the Defense Health Agency Hcd West under the Department of Defense. The work supports critical medical applications requiring precise radiological control and must be performed to sustain compliance during inspections, audits, and regulatory reviews. All activities must be fully traceable, precisely recorded, and aligned with current federal guidelines to ensure the continued licensure and safe deployment of SIR-Spheres in clinical settings.