Product Quality Research Institute - R&D Services

Product Quality Research Institute
About PQRI
The Product Quality Research Institute is a collaborative process involving FDA's Center for Drug Evaluation and Research (CDER), Industry and Academia. The mission of PQRI is to conduct research to generate scientific information to support regulatory policy. This initiative will help identify the types of product quality information that should be submitted in a regulatory filing to CDER. PQRI has been in development since January of 1996, guided by a Steering Committee composed of individuals representing the sponsoring organizations listed above.
The outcomes of PQRI will be focused on research projects whose results provide a continuing scientific basis for regulatory policy. As in the case of SUPAC IR, the research may support reduction in regulatory burden by decreasing the amount of information needed for a submission and/or regulatory filing.
Product Quality Research Institute
2107 Wilson Blvd,
Suite 700,
Arlington, Virginia 22201-3042
Tel: 703-248-4719
Fax: 703-525-7136
GanttS@pqri.org