The Office of Pharmaceutical Science, Center for Drug Evaluation and Research (CDER) is directed to identify the best practices for the manufacturing of high quality pharmaceutical products. Achieving this directive became increasingly difficult in era of doing more with less. The Office had to create a mechanism to utilize external resources - both funding and drug development expertise - to get the job done. The mechanism emerged as a Product Quality Research Institute (PQRI) which is a collaborative process involving CDER, Industry and Academia. The mission of PQRI is to conduct research to generate scientific information to support regulatory policy. This initiative helps identify the types of product quality information that should be submitted in a regulatory filing to CDER. The outcomes of PQRI are focused on research projects whose results provide a continuing scientific basis for regulatory policy. The research may support reduction in regulatory burden by decreasing the amount of information needed for a submission and/or regulatory filing.