Exam Name: Regulatory Affairs Certification (RAC) Global Scope
Certification Provider: RAPS
Corresponding Certification: RAC Regulatory Affairs Certification
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Updated: Sep 13, 2026
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Passing Score, Duration, No of question, languages, Format of the RAPS RAC-GS Certification Exam
RAC-GS exam dumps elaborated the detailed info about the exam. The overview of the info about Passing Score, Duration & Question for the RAPS RAC-GS Certification is given below:
- Exam Format: MCQs
- Passing score: 65%
- No. of questions: 100
- Languages: English
- Time Duration: 120 Minutes
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Introduction to the RAPS RAC-GS Certification Exam?
Regulatory Affairs Certification (RAC) Global Scope is simply called RAC-GS Certification Exam. This Certification Exam is designed by the RAPS to test the candidate's knowledge, skills, and abilities in Regulatory Affairs (R&D), Health Science (Pharmaceutical), Biotechnology, medicinal Device, and Public Health, to meet the requirements of Regulatory Affairs Professionals and other stakeholders. RAC-GS exam dumps can help you get your certification easily. The RAC-GS Certification Exam is also intended for use by educational and training institutions offering R&D programs and academic degrees related to regulatory affairs, health science, biotechnology, medical device, and public health. Investors, people in financial services, business analysts, and consultants are also eligible to take this exam. Labeling is granted to individuals who pass the exam. The candidates must then pass the RAC-GS Certification Exam as well as the RAPS RAC-GS Certification Exam.
RAPS RAC-GS Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Post-Market Surveillance | - Pharmacovigilance and safety reporting - Lifecycle management and variations |
| Topic 2: Regulatory Strategy and Compliance | - Regulatory strategy development - Quality systems and inspections |
| Topic 3: Regulatory Submissions | - Global marketing authorization applications - Dossier preparation (eCTD and regional formats) |
| Topic 4: Drug Development Lifecycle | - Preclinical and clinical development stages - Clinical trial design and regulatory requirements |
| Topic 5: Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
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