Nonclinical Regulation of Biomedical Products

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

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

• 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

Once your application is submitted, received, and processed, you will be able to access your Application Status Check. If you are required to provide further information regarding your proficiency in English, you will be able to complete the requirement in several ways, depending on your familiarity with English, and the frequency with which you use English each and every day:

• Non-native English-speaking applicants will be required to submit official and valid results from one of the following English Language Tests:
  • C1 Advanced or C2 Proficiency (Cambridge English)
  • Duolingo English Test (DET)
  • IELTS Academic
  • PTE Academic
  • TOEFL Internt-based Test (CEEB Code: 3667) Northeastern will accept either the in-person version completed in a test center, or the TOEFL iBT Home Edition
• However, based on your academic environment and the primary instructional language in either your high school or university, you may be eligible for a waiver. All waivers must be submitted through your Application Status Check. For additional information and to determine whether or not you are eligible for a waiver, please read the section below on waiving the English proficiency requirement.

Please note: Northeastern’s Admissions Committee reserves the right to request proof of English language proficiency from any applicant, regardless of citizenship or first language, at any time during the evaluation process.

• 1.Create your application

  Submit your application through The Common Application or the Coalition Application (both are accepted). Once you have created your application, please select Northeastern University to directly submit your application to us. Application fee of $75 or need-based fee waiver* *Northeastern accepts need-based fee waivers from the Common Application, the Coalition Application, as well as organizations such as the College Board and ACT, or in a written request from a school official.

• 2.Submit all required materials

  Double check to make sure that you have submitted all required materials. Even if your application has been submitted, we cannot begin reviewing your file until all of your required materials have been received. For applicants applying for the 2022-2023 academic year, Northeastern University is test-optional and does not require standardized testing to complete an application for admission.

• 3.Check your application status

  Within seven days of applying, you should receive a confirmation email containing your Northeastern University ID number and instructions for setting up your Application Status Check account. To ensure all of the necessary documents have been submitted, and for updates or information about your application, visit your application status check.