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Wednesday, May 24, 2017
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Essentials in US Regulatory Affairs Professional Certification Program (PRA00B1)

Certification Training Duration: 5.8 hours (the average time to complete the training program, including final assessments).
Credits Hours: 6
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $579.00


This online program includes the essentials for the requirements for obtaining approval for a new drug in the USA (a.k.a. NDA Process), preparing submissions in the CTD (Common Technical Document) Form, and human medicinal products in the US and EU. Courses that must be taken during this program include the following: Regulatory Affairs- The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA; Regulatory Affairs- Preparing Submissions in the Common Technical Document (CTD) Form; Regulatory Affairs- Essentials for Human Medicinal Products- US and EU.

The entire program must be viewed by students in order to pass a multiple-choice, online final assessment. A passing grade of 80% or more is required within 90 days of completing the course (for Professional Certification Programs, it is 180 days). Once all course requirements have been satisfied, a Certificate of Completion is immediately available. Course takers can take the final assessment any number of times, as needed in order to achieve a passing grade.

Benefits of Getting Certified at BioPharma Institute

The BioPharma Institute has proudly provided online training solutions for two decades and assisted individuals from thousands of corporations both abroad and in the United States. We have worked with companies such as Wyeth, 3M, Tyco Healthcare, Astra Zeneca, GE Healthcare, and more in the education of their employees, maintaining training records, and the improvement of their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at for more information.

Training Provided By: BioPharma Institute

BioPharma Institute LogoThe Essentials in US Regulatory Affairs Professional Certification Program Includes the Following Individual Courses:

Regulatory Affairs: Essentials for Human Medicinal Products – EU and US: This foundation-level module is the ideal intro for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to maintain and gain ap … Learn more

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form: The Common Technical Document is the mandatory format for regulatory submissions in Australia, Canada, Japan, the European Union, and, for the United States of America, it is strongly recommended. It is widely … Learn more

Regulatory Affairs: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA: An NDA (New Drug Application) is a regulatory vehicle through which sponsors formally propose that the FDA approve a new drug for marketing and sale in the USA. For successful STA approval, what format and cont … Learn more

For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email

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