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: Jul 31, 2026

Q & A: 100 Questions and Answers

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  • In the United States: 80,000 USD
  • In Canada: 80,000 CDN
  • In Australia: 70,000 AUD
  • In the UK: 65,000 GBP

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

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

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

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

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RAPS RAC-GS Exam Syllabus Topics:

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

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