Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of products regulated by the Food and Drug Administration (FDA). The Master of Science (MS) and Graduate Certificate in Regulatory Science programs focus on drugs and biologics, although aspects of diagnostics, devices, and nutritional products are also addressed. The Graduate Certificate in Regulatory Science provides a more limited course of study than the MS degree program.
Both programs cover all major areas of drug product and biologics regulatory science, including:
•Chemistry, Manufacturing, and Controls (CMC)
•Clinical Research
•Pharmacovigilance
•Phase IV Research (e.g., Pharmacoepidemiology)
•Drug and Biologics Discovery

The strength of the MS program is its science-driven approach to drug and biologic product development and regulation. The program covers regulatory affairs in a global manner, including the application of regulatory principles worldwide. The program is not limited to regulatory affairs, and features lectures and student activities that span the discovery of drugs/biologics to post-market activities, with a scientific emphasis on development pathways, including common challenges and science-based solutions.

The Graduate Certificate consists of the first two courses of the MS program, for a total of 12 credits. It can be completed in less than one year, and is designed for students who seek a more limited course of study or commitment than the MS degree, which requires less than two years and 30 credits to complete. Certificate students can apply for the MS program at a later date, if desired, and apply their completed courses towards the MS degree.

Graduates of the MS in Regulatory Science program will be fluent in the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.