Graduate Certificate in Nonclinical Regulation of Biomedical Products-Silicon Valley

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

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We’re committed to creating an education as unique as your career path. So, whether your goal is a new career or moving up in your field, our innovative programs will get you going your way.


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We work with you to map your path to your goal.


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From real-world case studies to employer-based projects, we prepare you to manage what comes next.


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Whatever you’re passionate about, you’ll find the classes to sharpen your specialty.


Study anywhere, on your time

Part-time or full-time, we move at your speed, to get you where you’re going.



Entry Terms

Fall, Spring, Summer, Winter

Completion Time

6-12 months

F1 Visa Eligible


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

  • 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

Get Set With a Custom Course Plan

Required Courses



Complete a minimum of 8 quarter hours from the following:


Now Let's Talk Admissions

You know where you are headed and you've seen how our program will lead you there. So let's get going. Here's what you need to know before you enroll.

  • Online application
  • 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.
  • Professional resumé
  • 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

Are You an International Student? Find out what additional documents are required to apply.

Admissions Details Learn more about the College of Professional Studies admissions process, policies, and required materials.

Finance Your Education We offer a variety of resources, including scholarships and assistantships.

How to Apply Learn more about the application process and requirements.

Cost and Tuition

Application Deadlines

Winter 2022

Recommended Admissions Deadline
Domestic application complete (first half start: January 10, 2022) December 20, 2021
Domestic application complete (second half start: February 22, 2022) February 8, 2022

Spring 2022

Recommended Admissions Deadline
Domestic application complete (first half start: April 11, 2022) March 28, 2022
Domestic application complete (second half start: May 23, 2022) May 9, 2022

Summer 2022

Recommended Admissions Deadline
Domestic application complete (first half start: July 11, 2022) June 27, 2022
Domestic application complete (second half start: August 8, 2022) July 25, 2022

Fall 2022

Recommended Admissions Deadline
Domestic application complete (first half start: September 19, 2022) September 6, 2022
Domestic application complete (second half start: October 31, 2022) October 17, 2022

Student Body Profile

Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.


  • Where They Work

    • Shire
    • Pfizer
    • Medtronic
    • Biogen
    • Teva Pharmaceuticals
  • What They Do

    • Legal
    • Research
    • Quality Assurance
    • Operations
    • Healthcare Services
  • What They're Skilled At

    • Regulatory Affairs
    • Pharmaceutical Industry
    • U.S. Food and Drug Administration
    • Clinical Trials
    • Standard Operating Procedure (SOP)


Learn more about Northeastern Alumni on Linkedin.