Northeastern’s Graduate Certificate in Nonclinical Biomedical Products equips you to understand, develop, and apply global compliance standards in areas separate from direct clinical patient care.

Coursework in this certificate program includes targeted explorations of the 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.

Upon completion, graduates will be able to 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

Program objectives

• 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

Unique Features

1. Choose from elective courses that cover a broad range of practical and relevant issues in the field
2. 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
3. Courses from this certificate can be applied toward the Master of Science in Regulatory Affairs