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Following is the prerequisite for the RAPS RAC-US Certification Exam:

  • You must be a member of RAPS, the Regulatory Affairs Professionals Society
  • You must have 3 to 5 years of experience in regulatory affairs.
  • You should have a Bachelor's degree or higher

A quick overview of the RAPS RAC-US Certification Exam:

Regulatory Affairs Certification US is simply called RAC-US Certification Exam. It is a rigorous, technical exam consisting of questions across two disciplines - Pharmaceutical and Medical Devices. The exam is administered through the RAPS website which also serves as a platform for the RAC certification program. Candidates need to pass both the RAC-Drugs exam and RAC-Devices exam in order to achieve RAC-US Certification. Clinical qualification is not required for this exam. RAC-US exam dumps will help you to get prepared for the exam, with ease.

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RAPS RAC-US Exam Syllabus Topics:

SectionObjectives
Postmarket Compliance- Pharmacovigilance and adverse event reporting
- Device vigilance and recalls
Premarket Requirements- Labeling and promotional compliance
- Marketing authorization pathways (NDA, ANDA, PMA, 510(k))
Quality Systems and Regulatory Operations- GxP systems (GMP, GCP, GLP)
- Inspections and regulatory audits
Product Development Lifecycle- Drug and device development stages
- Clinical trial frameworks and submissions (IND/IDE)
Regulatory Foundations- Regulatory ethics and compliance principles
- US regulatory structure and agencies (FDA overview)

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