Regulatory Compliance & FDA Submission Support

The contract requires comprehensive regulatory compliance support focused on FDA submissions and hazardous material documentation, specifically to meet Department of Defense standards for medical supply chain operations. The contractor must obtain formal FDA regulatory confirmation, manage EBS referrals, and ensure accurate, timely submission of critical documentation including Material Safety Data Sheets and proper hazard labeling, all aligned with current federal regulatory frameworks. This effort is essential for maintaining compliance and enabling seamless integration of medical supplies into the DLA logistics network. Performance is centered at WaterVliet, New York with a ZIP code of 12189-5000, and the work must be completed within a tight timeline, with proposals due by August 10, 2026. The solicitation falls under NAICS code 541611 for management consulting services, indicating a focus on advisory and procedural coordination rather than direct manufacturing or supply. As a subcontract under the Department of Defense’s Medical Supply Chain FSA, the contractor is expected to operate with high precision in regulatory navigation and administrative coordination to support defense medical logistics.