Before a drug product can be evaluated in the clinic, the FDA requires detailed product characterization and rigorous evaluation of safety. The environments in which these tests are conducted are held to a high standard of documentation, training, and personnel expertise to insure the quality and integrity of the data. Frameworks have been put forth by the FDA, in the form of GLP and GMP regulations that must be followed during these studies to meet the agency’s requirements. At UT Advance, we’ve built the regulatory environment necessary to meet FDA requirements and assembled the scientific expertise to design effective studies. Our goal is to assist researchers in academia and industry by providing the studies required for a successful FDA submission.