Radiopharmaceutical Manufacturing and Radiosynthesis

The contract outlines the GMP-compliant manufacturing of critical radiopharmaceuticals including Ga-68 DOTATATE, FDG, and Tc-99m based agents, requiring strict adherence to quality control protocols and regulatory standards throughout all production phases. The work must be performed at a facility in New Orleans with a zip code of 70119 and must include robust emergency continuity plans to ensure uninterrupted supply, particularly for time-sensitive diagnostic agents. Production processes must meet all applicable FDA and nuclear regulatory requirements with full documentation and traceability from raw materials to final product release. This is a subcontract under the Department of Veterans Affairs 256-NETWORK Contract Office 16, with a solicitation response deadline of August 8, 2026, and a posted date of July 24, 2026. The North American Industry Classification System code 325412 indicates a focus on pharmaceutical preparation manufacturing. The successful offeror must demonstrate proven capability in radiopharmaceutical radiosynthesis, validated quality assurance systems, and capacity to handle the unique logistical and safety challenges of radioisotope production. Continuous operational readiness and compliance with nuclear safety and transportation regulations are essential requirements.