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Last Updated: Aug 01, 2026

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RAPS RAC-GS exam is designed to assess the knowledge of regulatory professionals in multiple regions and industries. RAC-GS exam covers a wide range of regulatory topics, including regulations, guidelines, and procedures related to product development, manufacturing, clinical trials, and marketing authorization. The RAC-GS certification is an excellent way to showcase your regulatory knowledge and skills to employers and colleagues worldwide.

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The RAC-GS exam is designed to cover a wide range of topics related to global regulatory affairs. This includes regulations and laws related to different countries and regions, as well as the various organizations and agencies that regulate healthcare products around the world. RAC-GS exam also covers regulatory strategies, compliance, and the submission and approval process for healthcare products.

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RAPS RAC-GS Exam Syllabus Topics:

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