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Updated: Sep 05, 2026

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How to get ready for the RAPS RAC-GS Certification Exam

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The RAC-GS exam is an exam that covers all the content areas from the RAC-GS Core Curriculum, as well as the specific knowledge, skills, and abilities for each of the two examination sectors, Pharmaceuticals and Medical Devices. It is offered by the Global Standard for Regulatory Professionals (RAPS). The exam is intended for regulatory professionals with experience in regulatory affairs, in the pharmaceutical or medical device sector. In this article, we'll examine the topics covered on the exam, and provide insights into the content areas, as well as how you can prepare for the exam. We will also discuss the resources that you can use for the prep of the RAPS RAC-GS Certification Exam, including RAC-GS exam dumps. Moreover, we will provide information about the exam, like eligibility, registration, and fee, dates, and locations of the exam, the exam process, exam structure, the pass marks, etc. So, let's start exploring!

How much is the total Cost for taking the RAPS RAC-GS Certification Exam?

The cost for the RAPS RAC-GS Certification Exam is different for members and non-members. It is 490 USD for members and 615 USD for non-member of the RAPS.

RAPS RAC-GS Exam Overview:

Certification Vendor:Regulatory Affairs Professionals Society (RAPS)
Exam Name:Regulatory Affairs Certification (RAC) Global Scope Exam
Exam Number:RAC-GS
Exam Price:$605 (RAPS Member), $760 (Non-Member) - 2026 rates
Related Certifications:RAC-Devices
RAC-Drugs
Passing Score:70%
Available Languages:English
Real Exam Qty:150-180
Exam Format:Multiple Choice, Computer-Based, Application, Recall, Analysis
Certificate Validity Period:3 years
Exam Duration:210 minutes
Recommended Training:RAPS Fundamentals Textbooks
RAPS Online University
Exam Registration:Pearson VUE Scheduling
RAPS Official Application
Sample Questions:RAPS RAC-GS Sample Questions
Exam Way:Computer-based testing at Pearson VUE centers or online remote proctoring
Pre Condition:Bachelor's degree + 3 years regulatory experience; Master's + 2 years; Doctorate + 1 year; RAPS membership recommended
Official Syllabus URL:https://www.raps.org/certifications/rac

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RAPS RAC-GS Exam Syllabus Topics:

SectionWeightObjectives
Post-Market Compliance & Surveillance20%- Pharmacovigilance & Adverse Events
  • 1. Global Reporting Requirements
    • 2. Risk Management Plans
      - Labeling, Advertising & Changes
      • 1. Post-Approval Changes & Variations
        • 2. Global Labeling Rules
          Regulatory Submissions & Approval20%- Global Dossiers & Submission Formats
          • 1. National & Regional Application Routes
            • 2. CTD/eCTD Structure
              - Review Process & Interactions
              • 1. Deficiencies & Response Management
                • 2. Regulatory Authority Interactions
                  Global Regulatory Environment & Strategy35%- Regulatory Strategy & Planning
                  • 1. Global Market Access Strategy
                    • 2. Regulatory Intelligence & Risk Management
                      - International Regulatory Frameworks
                      • 1. ICH, WHO, IMDRF, ISO Guidelines
                        • 2. Regional Regulatory Systems
                          Product Development & Lifecycle Management25%- Chemistry, Manufacturing & Controls
                          • 1. GMP Requirements
                            • 2. Quality Systems & Documentation
                              - Clinical Research & Trials
                              • 1. GCP Compliance
                                • 2. Global Clinical Submissions

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