RAC-US study materials - RAPS RAC-US dumps VCE

RAPS RAC-US : Regulatory Affairs Certification (RAC) US

Exam Code: RAC-US

Exam Name: Regulatory Affairs Certification (RAC) US

Updated: Jul 24, 2026

Q & A: 100 Questions and Answers

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

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  • Languages: English
  • Passing score: 70%
  • No. of questions: 100
  • Duration: 02 Hours
  • Exam Format: Multiple choice

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  • In Canada: 95,000 CAD
  • In India: 70,000 INR
  • In the United States: 85,000 USD
  • In the United Kingdom: 75,000 GBP

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A quick overview of the RAPS RAC-US Certification Exam:

Regulatory Affairs Certification US is simply called RAC-US Certification Exam. It is a rigorous, technical exam consisting of questions across two disciplines - Pharmaceutical and Medical Devices. The exam is administered through the RAPS website which also serves as a platform for the RAC certification program. Candidates need to pass both the RAC-Drugs exam and RAC-Devices exam in order to achieve RAC-US Certification. Clinical qualification is not required for this exam. RAC-US exam dumps will help you to get prepared for the exam, with ease.

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RAPS RAC-US Exam Syllabus Topics:

SectionObjectives
Topic 1: Strategic Planning- Regulatory strategy development
  • 1. Product development strategy
  • 2. Risk-benefit assessment
  • 3. Regulatory pathway selection
Topic 2: Post-Approval and Lifecycle Management- Marketed product compliance
  • 1. Postmarket surveillance
  • 2. Adverse event reporting
  • 3. Inspections and audits
  • 4. Product changes and supplements
Topic 3: Premarketing- Product development and approval
  • 1. FDA interactions
  • 2. Submission preparation
  • 3. Clinical and nonclinical requirements
  • 4. Labeling requirements
Topic 4: Interfacing with Regulatory Agencies- Regulatory communication and negotiation
  • 1. Compliance management
  • 2. Responses to agency inquiries
  • 3. Meetings with regulators

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