Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs

Program Format
Application Deadlines
Fall Quarter, Winter Quarter, Spring Quarter, Summer Quarter (excluding F-1 visa applicants)
Credits Required for Graduation
16 Quarter Hours


The Graduate Certificate in Biopharmaceutical Domestic Regulatory Affairs is designed to provide students with a greater understanding of medical device regulation and the industry’s unique software development and validation issues. The program will also prepare students to assure compliance, reduce costs, and improve techniques governing acquisition and measurement.

Courses in the certificate program also apply toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices. This gives you the flexibility to complete a certificate and be well on your way to earning a degree if you later decide to continue your education.

Program Objectives

  • Assess international regulations
  • Provide an interpretation of the regulations’ impact on companies
  • Understand international regulatory requirements for countries where new products will be marketed

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