Nonclinical Regulation of Biomedical Products

  • Certificate
Location: Anywhere
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Why Global Nonclinical Regulation of Biomedical Products?

The Graduate Certificate in Nonclinical Biomedical Products provides a comprehensive understanding of evolving nonclinical global biomedical product regulatory standards and processes.

The Graduate Certificate in Nonclinical Biomedical Products provides students with an opportunity to understand, develop, and apply global compliance standards in areas that are separate and distinct from direct clinical patient care. This includes, but is not limited to, design and preclinical development processes, including in vitro and in vivo animal testing, in silico testing, small scale/large scale manufacturing process development and validation, development and maintenance of supply chains, as well as product handling and distribution.

In this program, students will have the opportunity to achieve the following learning outcomes:

  • Differentiate between the nonclinical vs. clinical aspects of the global biomedical product commercialization process from a regulatory compliance perspective
  • Explain the compliance-associated requirements needed to successfully practice professional nonclinical work within the global biomedical products industry
  • Describe the nonclinical regulatory standards utilized by the United States Food and Drug Administration (FDA) and other global regulatory agencies to evaluate the safety and efficacy of new and existing biomedical products employed by healthcare practitioners in various patient settings
  • Apply fundamental global nonclinical regulations to the biomedical product commercialization process, including therapy design, manufacturing process development and validation, cybersecurity, and supply chain risk management

Unique Features

  • Online format provides flexibility to working professionals
  • Choose from elective courses that cover a broad range of practical and relevant issues in the field
  • The BTC 4450 Quality Control and Validation Issues course was developed in collaboration with quality assurance professionals from Vertex Pharmaceuticals and other external pharmaceutical industry partners
  • Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices

What you'll study

General Requirements

Graduate Certificate in Nonclinical Regulation of Biomedical Products General Requirements

Required Courses

RGA 6405 - Nonclinical Regulations in Biomedical Product Commercialization
RGA 6410 - Fundamentals of CMC Regulations and Methods


Complete a minimum of 8 quarter hours from the following:

RGA 6000 - Introduction to Food and Drug Administration (FDA) Pharmaceutical Regulation
RGA 6001 - Introduction to Food and Drug Administration (FDA) Medical Device Regulation
RGA 6112 - Biomedical Intellectual Property Management Strategy: Patents and Trade Secrets
RGA 6210 - Strategic Planning and Project Management for Regulatory Affairs
RGA 6233 - Application of Quality System Regulation in Medical Device Design and Manufacturing
RGA 6234 - Risk Management: Compliance and Processes
RGA 6248 - Global Regulatory Operations
RGA 6310 - Regulatory Documentation Processes
RGA 6420 - Global IVD Regulations and Submissions
RGA 6460 - Intellectual Property in the Life Sciences
RGA 6463 - Regulatory Strategy for Product Development and Life-Cycle Management

This program requires successful completion of a minimum of 16 credit hours that meet the degree requirements.

Did You Know?

A graduate certificate can boost your earnings by an average of 25% (Washington Post, 2012).

Did You Know?

About 137,000 new regulatory affairs jobs were filled in 2018.

Average Time to Completion

1 year



Entry Terms


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