Updated: Sep 15, 2026
No. of Questions: 100 Questions & Answers with Testing Engine
Download Limit: Unlimited
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Details about 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.
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
|---|---|
| Exam Name: | RAC Global Scope Examination (RAC-GS) |
| Exam Number: | RAC-GS |
| Exam Format: | Computer-based multiple-choice exam |
| Available Languages: | English |
| Related Certifications: | RAC Drugs RAC Devices RAC US |
| Certificate Validity Period: | 3 years (recertification required) |
| Recommended Training: | RAPS Learning Center |
| Exam Registration: | RAPS Certification Portal |
| Sample Questions: | RAPS RAC-GS Sample Questions |
| Exam Way: | Computer-based testing at authorized test centers or online proctored delivery (availability may vary by region) |
| Pre Condition: | No formal prerequisite required; typically recommended 3+ years of regulatory affairs experience or equivalent professional background. |
| Official Syllabus URL: | https://www.raps.org/certification |
| Section | Objectives |
|---|---|
| Topic 1: Regulatory Foundations | - Global regulatory systems and authorities - Regulatory ethics and compliance principles |
| Topic 2: Regulatory Strategy and Compliance | - Regulatory strategy development - Quality systems and inspections |
| Topic 3: Drug Development Lifecycle | - Preclinical and clinical development stages - Clinical trial design and regulatory requirements |
| Topic 4: Regulatory Submissions | - Dossier preparation (eCTD and regional formats) - Global marketing authorization applications |
| Topic 5: Post-Market Surveillance | - Pharmacovigilance and safety reporting - Lifecycle management and variations |
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