Regulatory Compliance & Quality Assurance for Drug Storage

The contract titled Regulatory Compliance & Quality Assurance for Drug Storage focuses on providing ongoing monitoring, audit readiness support, and quality assurance services specifically for the storage of investigational drugs, ensuring full compliance with FDA and NIH standards. The work will involve regular inspections, documentation review, process validation, and corrective action implementation to maintain the integrity and regulatory compliance of drug storage conditions throughout the investigational drug lifecycle. All activities must adhere to current good manufacturing practices and federal guidelines to support the safety, efficacy, and traceability of clinical trial materials. This is a small business set-aside subcontract under the NAICS code 541611 for management consulting services, issued by the National Institutes of Health under the Department of Health and Human Services. The opportunity was posted on July 2, 2026, with a response deadline of July 11, 2026. Performance is required to take place in Frederick, Maryland, 21703. The contract structure is limited to small business entities, and no point of contact information is provided in the solicitation. Participation requires demonstrated expertise in pharmaceutical storage compliance, regulatory audit preparation, and quality systems management within the context of federal clinical research requirements.