Request for Project Proposals: Advanced Research and Development of Medical Countermeasures Through Agile and Distributed End-to-End Drug Manufacturing

The Administration for Strategic Preparedness and Response, Industrial Base Management and Supply Chain (APSR IBMSC) is seeking to establish advanced research and development of medical countermeasures through agile and distributed drug substance and drug product manufacturing capacities. This includes establishing end-to-end manufacturing capacities under current good manufacturing practices (cGMP) and all associated regulatory filings to include drug master files (DMFs), New Drug Applications, (NDAs) and Abbreviated New Drug Applications (ANDAs). This scope also includes the use of qualified laboratories for product verification, environmental and shelf-life testing, and adherence to industry-recognized consensus standards applicable to performance and its goals (e.g., ISO, ASTM).