Regulatory Compliance and Quality Assurance Support

The contract seeks comprehensive regulatory compliance and quality assurance support specifically tailored to FDA requirements for controlled pharmaceutical submissions to the Department of Defense. The work involves coordinating with product specialists through the EBS system to ensure accurate and timely submission of documentation, maintaining strict adherence to FDA regulations throughout the lifecycle of pharmaceutical products under review. This includes managing complex documentation processes, ensuring alignment with federal standards, and facilitating seamless communication between technical teams and regulatory bodies to support defense medical supply chain needs. The contractor must deliver services that uphold the highest standards of quality control and regulatory integrity, with a focus on controlled substances and other regulated pharmaceuticals. All activities are to be performed in support of the Medical Supply Chain Pharmaceutical FSA, with the place of performance not specified but expected to align with DoD operational and logistical requirements. The subcontract is open for response until May 15, 2026, with NAICS code 541611 indicating management, scientific, and technical consulting services as the primary category. The opportunity is posted under the DLA DIBBS platform and requires proposers to possess deep expertise in federal pharmaceutical regulatory processes and DoD supply chain protocols.