Graduate Certificate in Nonclinical Regulation of Biomedical Products – Online
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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Overview
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
- 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
Career Prospects
Beginning your journey with us is a big decision. But it's a smart one. Your field is evolving rapidly. That's why we're constantly innovating our programs to anticipate your industry's needs. So, no matter where your field goes, you can lead the way.
Average Salary, Compliance Officer
Average Salary, Project Management Specialist
Get Set With a Custom Course Plan
Please note: The following is a sample curriculum and is subject to change. Enrolled students should reference the academic catalog for current program requirements.
Required Courses
Credits 4.00 | ||
Credits 4.00 |
Electives
Complete a minimum of 8 quarter hours from the following:
Credits 2.00 | ||
Credits 2.00 | ||
Credits 4.00 | ||
Credits 4.00 | ||
Credits 4.00 | ||
Credits 4.00 | ||
Credits 2.00 | ||
Credits 4.00 | ||
Credits 4.00 | ||
Credits 2.00 | ||
Credits 4.00 |
Distinguished Faculty
"Experienced regulatory professionals are in demand. A graduate degree in regulatory affairs will help advance your career."
— Professor Stephen Amato
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Stephen Amato
Global Regulatory Affairs, Market Access and Life Sciences Executive & Education AdministratorFull bio
Cost and Tuition
Tuition
Estimated Total Tuition
This is an estimate based on the tuition rates for Academic Year 2024-2025 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.
Application Deadlines
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.
Did you know?
Below is a look at where our Regulatory Affairs alumni work, the positions they hold, and the skills they bring to their organization.
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Where They Work
- Shire
- Pfizer
- Medtronic
- Biogen
- Teva Pharmaceuticals
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What They Do
- Legal
- Research
- Quality Assurance
- Operations
- Healthcare Services
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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.
Related Programs
Admissions
- 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
- 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.)
- 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.
Let’s Find Your Path Forward
Our enrollment representatives can walk you through the application process and help you explore your program options.
Call Toll Free: 877.668.7727