Purchase RAPS : RAC-GS Exam Materials and then pass exam easily

Last Updated: Aug 23, 2026

No. of Questions: 100 Questions & Answers with Testing Engine

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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!

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RAPS RAC-GS Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Post-Market Compliance & Surveillance20%- Labeling, Advertising & Changes
  • 1. Post-Approval Changes & Variations
    • 2. Global Labeling Rules
      - Pharmacovigilance & Adverse Events
      • 1. Risk Management Plans
        • 2. Global Reporting Requirements
          Topic 2: Product Development & Lifecycle Management25%- Clinical Research & Trials
          • 1. Global Clinical Submissions
            • 2. GCP Compliance
              - Chemistry, Manufacturing & Controls
              • 1. GMP Requirements
                • 2. Quality Systems & Documentation
                  Topic 3: Global Regulatory Environment & Strategy35%- International Regulatory Frameworks
                  • 1. ICH, WHO, IMDRF, ISO Guidelines
                    • 2. Regional Regulatory Systems
                      - Regulatory Strategy & Planning
                      • 1. Regulatory Intelligence & Risk Management
                        • 2. Global Market Access Strategy
                          Topic 4: Regulatory Submissions & Approval20%- Global Dossiers & Submission Formats
                          • 1. National & Regional Application Routes
                            • 2. CTD/eCTD Structure
                              - Review Process & Interactions
                              • 1. Regulatory Authority Interactions
                                • 2. Deficiencies & Response Management
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