The Graduate Certificate in Nonclinical Biomedical Products provides a comprehensive understanding of evolving nonclinical global biomedical product regulatory standards and processes.
Duration of Program
Meets F1 Visa Requirements
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
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
A graduate degree or certificate from Northeastern—a top-50 university—can accelerate your career through rigorous academic coursework and hands-on professional experience in the area of your interest. Apply now—and take your career to the next level.
How to Apply Learn more about the application process and requirements.
Statement of purpose (500–1000 words): Identify your educational goals and expectations of the program. Please be aware that Northeastern University's academic policy on plagiarism applies to your statement of purpose.
Unofficial undergraduate transcripts; official transcripts required at the time of admission
Two letters of recommendation from individuals who have either academic or professional knowledge of your capabilities such as a faculty member, colleague, or mentor, preferably one from your current employer
English language proficiency proof. Students for whom English is not their primary language must submit one of the following:
Official associate or bachelor's degree transcript from an accredited college or university in the U.S., stating degree conferral and date
TOEFL, IELTS, PTE, Duolingo, or NU Global Exam scores
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
Please note: This curriculum is for marketing purposes only and is subject to change. Official curriculum can be found within the course catalog.
Northeastern's signature experience-powered learning model has been at the heart of the university for more than a century. It combines world-class academics with professional practice, allowing you to acquire relevant, real-world skills you can immediately put into action in your current workplace. This makes a Northeastern education a dynamic, transformative experience, giving you countless opportunities to grow as a professional and person.
Our faculty represents a wide cross-section of professional practices and fields ranging from finance to education to biomedical science to management to the U.S. military. They serve as mentors and advisors and collaborate alongside students to solve the most pressing global challenges facing established and emerging markets.
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Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.