Regulatory Compliance & Quality Assurance (QA) Support
Contract Overview
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The contract requires strict adherence to FDA, DEA, and DLA quality standards for pharmaceutical delivery, with an emphasis on full lot traceability, mandatory certificates of analysis, and a zero tolerance policy for any variance in product quality or documentation. All activities must ensure regulatory compliance throughout the supply chain, with no room for deviation in handling, testing, or reporting procedures. The subcontractor is expected to implement rigorous quality assurance protocols to guarantee that every pharmaceutical shipment meets the exacting requirements set forth by federal regulatory bodies and the Defense Logistics Agency. Performance is bound to the specifications of the Department of Defense and centered on maintaining the integrity of pharmaceutical logistics under the NAICS code 541690, which covers other scientific and technical consulting services. The work is tied to contract SPE2DX25D9900 and delivery order SPE2DP26F8701, and although the specific location of performance is not detailed, the requirements apply universally across all operational contexts. Compliance is non-negotiable, and failure to meet these standards could result in immediate contract breach, making precision, documentation, and accountability the foundation of all tasks performed under this agreement.
General Info
Agency
NAICS
Place of Performance
Not specifiedSet-Aside
Documents
This scope was carved out of SPE2DP26F8701.
The full solicitation package (3 documents), including the RFP, is on the prime solicitation, not on this scope.
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