Drug Supply & Investigational Medication Logistics

The contract encompasses the end-to-end management of investigational drug supply, including packaging, labeling, blinding, storage, and distribution to clinical trial sites, all performed in strict compliance with current good manufacturing practices and regulatory standards set by the FDA and ICH. All activities must ensure product integrity, traceability, and adherence to protocol-specific requirements to support the safety and efficacy of clinical research conducted under the National Institutes of Health NICHD. The work is subject to a Total Small Business Set-Aside under SBA guidelines, meaning only small businesses are eligible to bid, and the NAICS code 325412 designates the primary industry classification as pharmaceutical preparation manufacturing. Submission deadlines are firm, with proposals due by June 10, 2026, at 8:30 PM ET, and the contract is structured as a subcontract under the Department of Health and Human Services. The performance location is not specified, but operations must support global or multi-site clinical trials as needed. Compliance with cGMP, regulatory documentation, chain of custody, and real-time inventory control are essential requirements. The contracting entity is the National Institutes of Health through its NICHD division, emphasizing a high standard of quality and accountability in the handling of investigational medications throughout the clinical development lifecycle.