Radiopharmaceutical Quality Assurance and Compliance Testing
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This contract involves independent testing services focused on ensuring the quality and compliance of Pylarify radiopharmaceutical batches before their clinical use. The scope of work includes assessing radiochemical purity, sterility, and endotoxin levels, while verifying adherence to the United States Pharmacopeia standards, specifically USP <823>, as well as FDA regulatory requirements. The testing aims to guarantee that all Pylarify batches meet stringent quality assurance criteria critical for patient safety and effective clinical application. Issued by the Department of Veterans Affairs through the 245-NETWORK Contract Office 5, this subcontract falls under the NAICS code 541380, which corresponds to testing laboratories. The contract was posted on January 5, 2026, and is intended to strengthen regulatory compliance and product integrity within the radiopharmaceutical supply chain. The services provided under this contract support clinical programs by validating the safety and performance of Pylarify, a radiopharmaceutical utilized in medical diagnostics.
General Info
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Documents
This scope was carved out of 36C24526Q0034.
The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.
6505--Radiopharmaceutical - Pylarify
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