RAPS RAC-GS : Regulatory Affairs Certification (RAC) Global Scope

RAC-GS real exams

Exam Code: RAC-GS

Exam Name: Regulatory Affairs Certification (RAC) Global Scope

Updated: Aug 05, 2026

Q & A: 100 Questions and Answers

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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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The RAPS RAC-GS Certification Exam has a contract with “Scantron”. Therefore, if you wish to take the RAPS RAC-GS Certification Exam, you will need to sign up for a Scantron account. This is needed in order to receive an official RAPS RAC-GS Certification Exam booklet. You can get help from the RAC-GS exam dumps to know more about the locations. The location of the Scantron office for your country can be found on the official website of the company. Accessories and consumables are not included in the registration charges.

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Topics covered by the RAPS RAC-GS Certification Exam:

RAC-GS exam dumps will cover the following topics of the RAC-GS Certification Exam:

  • Health Science: 10%
  • Public Health: 10%
  • Bio-Technology: 20%
  • Pharmaceuticals: 25%
  • Medical Devices: 35%

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RAPS RAC-GS Exam Syllabus Topics:

SectionObjectives
Regulatory Strategy and Compliance- Regulatory strategy development
- Quality systems and inspections
Drug Development Lifecycle- Preclinical and clinical development stages
- Clinical trial design and regulatory requirements
Regulatory Submissions- Dossier preparation (eCTD and regional formats)
- Global marketing authorization applications
Regulatory Foundations- Regulatory ethics and compliance principles
- Global regulatory systems and authorities
Post-Market Surveillance- Lifecycle management and variations
- Pharmacovigilance and safety reporting

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