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Last Updated: Aug 13, 2026

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Introduction to 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.

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Passing Score, Duration, No of question, languages, Format of the RAPS RAC-GS Certification Exam

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  • Exam Format: MCQs
  • Languages: English
  • Passing score: 65%
  • No. of questions: 100
  • Time Duration: 120 Minutes

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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!

Get to know about the benefits that you can enjoy after getting the RAPS RAC-GS Certification:

Following are a few benefits that you can get after being certified with the assistance of the RAC-GS exam dumps:

  • Career Growth and more salary: The RAPS RAC-GS certification will enhance your career growth and increase your salary. It also helps you to increase your chances of landing a job in Regulatory Affairs. The certification also acts as an advantage when applying for jobs.

  • Credential: As a RAPS RAC-GS certified professional you will be able to show your RAC-GS certification to potential employers or clients. If you have finished the course, it will be noted on your resume or CV. It will act as a credential.

  • Personal Development and Self-Improvement: It helps you to develop yourself professionally. It will also help you to improve your knowledge, skills, and abilities. Proprietary knowledge about the product that you are dealing with helps you to identify problems that can arise in the future.

  • Professional Recognition: The RAPS RAC-GS certification will be accepted by many employers, and it gives your resume an added value. Privacy is a huge concern nowadays, and this certification does not give away any personal information.

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RAPS RAC-GS Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Global Regulatory Environment & Strategy35%- Regulatory Strategy & Planning
  • 1. Regulatory Intelligence & Risk Management
    • 2. Global Market Access Strategy
      - International Regulatory Frameworks
      • 1. ICH, WHO, IMDRF, ISO Guidelines
        • 2. Regional Regulatory Systems
          Topic 2: 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
                  Topic 3: Product Development & Lifecycle Management25%- Clinical Research & Trials
                  • 1. Global Clinical Submissions
                    • 2. GCP Compliance
                      - Chemistry, Manufacturing & Controls
                      • 1. Quality Systems & Documentation
                        • 2. GMP Requirements
                          Topic 4: Post-Market Compliance & Surveillance20%- Labeling, Advertising & Changes
                          • 1. Global Labeling Rules
                            • 2. Post-Approval Changes & Variations
                              - Pharmacovigilance & Adverse Events
                              • 1. Global Reporting Requirements
                                • 2. Risk Management Plans
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