Regulatory Compliance and Quality Assurance Support
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The contract seeks support for regulatory compliance and quality assurance related to diagnostic reagents, specifically focusing on FDA and CLIA documentation requirements. This includes ensuring accurate lot traceability, preparing certificates of analysis, and facilitating quality system audits to maintain regulatory adherence. The work is tied to the Indian Health Service under the Department of Health and Human Services and is designated as an Indian Small Business Economic Enterprise set aside, targeting qualified Native American-owned small businesses. The performance location is in Lawton, Oklahoma, with a zip code of 73507, and the NAICS code 541611 indicates the scope falls under medical and diagnostic laboratory services. The opportunity was posted on August 7, 2026, with a response deadline of August 14, 2026, at 6:00 PM, and is classified as a subcontract.
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Lawton, OK, 73507, USASet-Aside
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