Prepare with RAPS RAC-GS exam torrent, pass for sure

Updated: Jul 20, 2026

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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!

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 Duration:210 minutes
Certificate Validity Period:3 years
Passing Score:70%
Real Exam Qty:150-180
Exam Format:Multiple Choice, Computer-Based, Recall, Application, Analysis
Available Languages:English
Exam Price:$605 (RAPS Member), $760 (Non-Member) - 2026 rates
Related Certifications:RAC-Drugs
RAC-Devices
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
Topic 1: Global Regulatory Environment & Strategy35%- Regulatory Strategy & Planning
  • 1. Global Market Access Strategy
    • 2. Regulatory Intelligence & Risk Management
      - International Regulatory Frameworks
      • 1. Regional Regulatory Systems
        • 2. ICH, WHO, IMDRF, ISO Guidelines
          Topic 2: 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
                  Topic 3: Regulatory Submissions & Approval20%- Global Dossiers & Submission Formats
                  • 1. CTD/eCTD Structure
                    • 2. National & Regional Application Routes
                      - Review Process & Interactions
                      • 1. Regulatory Authority Interactions
                        • 2. Deficiencies & Response Management
                          Topic 4: Product Development & Lifecycle Management25%- Chemistry, Manufacturing & Controls
                          • 1. Quality Systems & Documentation
                            • 2. GMP Requirements
                              - Clinical Research & Trials
                              • 1. Global Clinical Submissions
                                • 2. GCP Compliance

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