Request for Project Proposals: Vendor Managed Inventory (VMI) Capabilities for APIs Used in Medical Countermeasure FDF Drug Products

ASPR IBMSC is seeking to establish vendor managed inventory (VMI) capabilities for active pharmaceutical ingredients (APIs) used in medical countermeasure finished dose form (FDF) drug products. This scope includes providing a VMI capabilities for the procurement, storage, management, conversion, and distribution of qualified APIs from FDA-inspected suppliers with Drug Master Files on record; demonstration of analytical chemistry capabilities for acceptance and retesting of APIs; and storage, rotation, and replenishment of APIs under current good manufacturing practice (cGMP) conditions. This scope also includes the use of qualified laboratories for product verification, environmental and shelf-life testing, and adherence to industry-recognized consensus standards (e.g., ISO, ASTM). This scope also includes supply chain resilience-type activities.