Certified Regulatory Affairs Professional

CRAP : Certified Regulatory Affairs Professional

CRAP is administered by AIBMC (The American Institute for Business Management and Communication); one of the most renowned institutes for business management and communications in the United States. By earning CRAP candidates demonstrate that they have mastered the Regulatory Affairs management body of knowledge, obtained the skills of a professional Regulatory Affairs manager, and committed to AIBMC core values and code of ethics.

CRAP Certificate Preparation
If you are studying in order to prepare for the CRAP exam; AIBMC provides candidates with training sessions for many of the exam questions. AIBMC also provide thorough training for the exam modules using its learning system through authorized training providers and prometric centers worldwide.

AIBMC CRAP Recertification
Once you have passed the CRAP exam and received your certificate, you will need to stay up to date on developments in Regulatory Affairs management practices. To prove you have maintained and updated your Regulatory Affairs management knowledge and skills, AIBMC requires that you recertify every 4 years. (please refer to recertification for more info)


  • A passing score on the CRAP Examination.
  • Bachelor Degree in any field and; OR
  • A minimum of 1 year experience in any related Regulatory Affairs management duties or assignments.
  • A Minimum of 25 hours of project management approved training. (Optional for those with a Degree)

Exam Format:
The CRAP examination is a 3-hour exam, Multiple Essays Direct Questions Examination. The exam is given in booklet form.

Exam Outline:

  1. The Aims and Structure of Regulations
  2. Regulatory Strategy
  3. Drug Discovery and Development
  4. Non-Clinical Studies
  5. Clinical Trials
  6. Marketing Authorization
  7. Authorization of Veterinary Medicines
  8. Variations to the Drug Authorization Process
  9. Medical Devices
  10. Authorization of Medical Devices
  11. Good Manufacturing Practice (GMP)
  12. Oversight and Vigilance

Please e-mail us at info@aibmc.org for any other inquiries. International candidates, please contact our authorized representatives in your region.

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