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College of Professional Studies

Nonclinical Regulation of Biomedical Products

Certificate

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

Program curriculum Explore College of Professional Studies
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Program Format
On ground
Time Commitment
Part Time
Duration
6 - 12 Months
Entry Term(s)
Fall, Spring, Summer, Winter
Meets F1 visa requirements
No
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Program overview

Advance in biomedical regulation

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.

Choose from elective courses that cover a broad range of practical and relevant issues in the field, many of which were developed in collaboration with quality assurance professionals and pharmaceutical industry partners.

Admissions

Apply to the program

A graduate degree or certificate from Northeastern can accelerate your career through rigorous academic coursework and real-world professional experience in your area of interest. Apply to take your career to the next level.

Our admissions process operates on a rolling basis; however, we do recommend the application guidelines below to ensure you can begin during your desired start term:

Domestic Application Guidelines

International Application Guidelines*

*International deadlines are only applicable if the program is F1 compliant.


  • Online application

  • Professional resumé

  • Unofficial undergraduate transcripts; official transcripts required at the time of admission

    • The Foreign Credential Evaluation (FCE) is a required assessment of all transcripts and documents from non-U.S. accredited post-secondary education institutions. (Review the FCE requirements by country.)

  • 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

  • Other materials may be required

Program objectives

Prepare for success

Advance your career in biomedical regulatory affairs with a strong foundation in regulatory standards, compliance, clinical considerations, and more.

Understand commercialization

Differentiate between the nonclinical vs. clinical aspects of the global biomedical product commercialization process from a regulatory compliance perspective.

Explain compliance requirements

Explain the compliance-associated requirements needed to successfully practice professional nonclinical work within the global biomedical products industry.

Apply FDA standards

Describe the nonclinical regulatory standards used by the United States Food and Drug Administration (FDA) and global regulatory agencies to evaluate the safety and efficacy of biomedical products employed by healthcare practitioners.

Apply global regulations

Apply key global nonclinical regulations to the biomedical product commercialization process, including therapy design, manufacturing process development, cybersecurity, and supply chain risk management.

Connect with us

Want more information?

We’re here to answer your questions about this program, the application process, and more. Complete the form below to receive additional program details and speak with a member of our enrollment team. 

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Degree building

Stack your certificate

Earning a graduate certificate is a fast and affordable way to acquire specialized skills while building toward your master’s degree. Upon completion of this certificate program, you may be able to apply your credits to an eligible master’s program, saving time and money on your degree.

Some of the eligible master’s programs for this certificate include:

Contact an enrollment counselor to learn more about eligibility requirements.

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Cost of attendance

Tuition and financial aid

  • $15,120
    Tuition in USD

Estimated Total Tuition

This is an estimate based on the tuition rates for Academic Year 2025-2026 and does not include any fees or other expenses. Some courses and labs have tuition rates that may increase or decrease total tuition. Tuition and fees are subject to revision by the president and Board of Trustees at any time. Select programs at select campuses offer additional scholarships of up to 25% off the listed price for domestic students studying on campus. For more detailed information, please visit Student Financial Services.

For students interested in pursuing financial assistance or educational loans, additional educational costs, known as Cost of Attendance (COA) components, can be included in the calculation of aid and loan eligibility. Components may include food, housing, books, course materials, supplies, equipment, transportation, personal expenses, and the cost of obtaining a first professional licensure. You can find comprehensive details on the Student Financial Services website. Please keep in mind that COA can vary significantly depending on academic program, enrollment intensity, and individual circumstances.

There are many ways to pay for your education, including scholarships, financial aid, and more. Connect with a financial counselor to learn about your options and make your dream a reality.

Visit tuition & financial aid
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