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Updated: Aug 14, 2026

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Get to know about the main objectives of the RAPS RAC-US Certification Exam:

The main objective of the RAPS RAC-US Certification exam is to test your knowledge in the area of pharmaceutical and medical devices regulations and compliance. Candidates should be familiar with the current regulatory environment, as well as the latest developments in the regulatory landscape. Additionally, candidates should understand how a given company's products and services are regulated, and how those regulations affect the company. Gatherings of the knowledge of the topics covered in the exams can be found in the RAC-US exam dumps. Candidates should also have the ability to apply this knowledge to analyze and interpret the data found in various reports or articles and come up with a solution on how to regulate a company's products and services. Installed knowledge in each of these areas is essential to pass the RAC-US Certification exam.

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

Info about the minimum score required to pass, Duration & Question for the RAPS RAC-US Certification is given below. If you want detailed info, you can get in touch with the RAC-US exam dumps:

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

RAPS RAC-US Exam Overview:

Certification Vendor:Regulatory Affairs Professionals Society (RAPS)
Exam Name:Regulatory Affairs Certification (RAC) United States
Exam Number:RAC-US
Certificate Validity Period:3 years (requires recertification)
Related Certifications:RAC-EU
RAC-Drugs
RAC-Devices
RAC-Global
Exam Price:Member: $605 USD; Non-Member: $760 USD (2026 rates)
Real Exam Qty:100
Exam Format:Computer-based, Multiple-choice, Recall, Application, Analysis
Available Languages:English
Exam Duration:120 minutes
Passing Score:Scaled score 70 (range 0–99)
Recommended Training:RAPS Official RAC Preparation Resources
RAC-US Candidate Guide
Exam Registration:RAPS RAC Application Portal
Sample Questions:RAPS RAC-US Sample Questions
Exam Way:Online remote proctored or in-person at authorized testing centers
Pre Condition:Bachelor's + 3 years experience; Master's + 2 years; Doctorate + 1 year; or 10+ years regulatory experience
Official Syllabus URL:https://www.raps.org/certifications/rac/rac-us

RAPS RAC-US Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Submissions and Regulatory Interactions24%- Regulatory intelligence and planning
- FDA review processes and communications
- Modifications, supplements, and variations
- eCTD and electronic submission formats
Topic 2: Strategic Planning24%- Regulatory pathways and marketing authorization
- US regulatory environment and framework
- Product lifecycle strategy
- Risk management and quality systems
Topic 3: Post-Market and Compliance24%- Inspections, audits, and enforcement actions
- Compliance and continuous improvement
- Reporting obligations and adverse events
- Post-marketing surveillance and pharmacovigilance
Topic 4: Development and Pre-Market28%- Labeling and advertising regulations
- Clinical trials and non-clinical studies
- Design controls and technical documentation
- CMC and manufacturing requirements

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