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Tuesday, June 27, 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 professional certification program describes the essential requirements for obtaining approval of a new drug in the USA, the ‘NDA Process’. The program describes preparing submissions using the Common Technical Document (CTD) Form and requirements for obtaining approval of human medicinal products in the US and EU. Courses that are included in this program are the following: The NDA Process: Requirements for Obtaining Approval for a New Drug in the USA; Preparing Submissions in the Common Technical Document (CTD) Form; Essentials for Human Medicinal Products- US and EU.

The entire program must be viewed by students. In order to pass, a score of 80% or better is necessary on each of the multiple-choice, online final assessments. Once all course requirements have been satisfied, a professional certification is immediately achieved. 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

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. The has proudly provided online training solutions for two decades and assisted individuals from thousands of corporations both abroad and in the United States.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.

Training Provided By:
Website: 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 training program is the ideal introduction for entrants new to the field of pharmaceutical compliance and regulatory affairs. It describes the principal requirements needed in order to mai … Learn more

Regulatory Affairs: Preparing Submissions in the Common Technical Document (CTD) Form: The Common Technical Document (CTD) 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 w … 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 approval, what format and content … Learn more

For more information on the’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) 111-1111, or email

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