Quality Assurance and Regulatory Compliance Support
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The contract seeks a subcontractor to provide comprehensive quality assurance and regulatory compliance support for FDA, DLA, and DoD regulatory requirements, focusing on critical documentation such as Safety Data Sheets (SDS), stability reports, and inspection readiness activities aligned with FAR 52.246-2. The scope requires expert handling of regulatory submissions and ongoing compliance to ensure products meet rigorous federal standards for medical supply chains, with all work tied to performance at APO, ZIP 09898. The subcontractor must demonstrate proven experience in navigating complex regulatory environments and maintaining documentation integrity under federal oversight. The opportunity is posted under NAICS code 541611, indicating professional, scientific, and technical services related to scientific and technical consulting. Responses are due by August 3, 2026, and the contract is designated as a subcontract within the Department of Defense’s Medical Supply Chain MD Surg FSF framework. The place of performance is fixed at APO, and the contracting activity is managed through the DLA’s procurement portal, with no set-aside classification specified. The success of this engagement hinges on consistent adherence to federal compliance protocols and the ability to deliver accurate, timely, and audit-ready documentation throughout the product lifecycle.
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NAICS
Place of Performance
APO, AE, 09898, USSet-Aside
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