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Updated: Aug 02, 2026
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RAPS RAC-US Exam Overview:
| Certification Vendor: | Regulatory Affairs Professionals Society (RAPS) |
| Exam Name: | Regulatory Affairs Certification (RAC) US |
| Exam Number: | RAC-US |
| Real Exam Qty: | 100 |
| Related Certifications: | RAC-Global RAC-EU RAC-Canada RCC |
| Available Languages: | English |
| Exam Format: | Computer-based, Multiple-choice, Recall, Application, Analysis |
| Exam Price: | USD 605 (RAPS Member), USD 760 (Non-Member) |
| Exam Duration: | 120 minutes |
| Certificate Validity Period: | 3 years |
| Passing Score: | Scaled score of 75 |
| Sample Questions: | RAPS RAC-US Sample Questions |
| Exam Way: | Pearson VUE Test Center or Online Proctored Exam (OnVUE) |
| Pre Condition: | Bachelor's degree and 3 years regulatory experience; or Master's degree and 2 years regulatory experience; or Doctorate degree and 1 year regulatory experience. |
| Official Syllabus URL: | https://www.raps.org/certifications/rac |
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.
Who can take the RAPS RAC-US Certification Exam?
The targeted audience for the RAPS RAC-US certification exam is regulatory professionals involved in the pharmaceutical and medical device industries. However, candidates from any related field can take the RAPS RAC-US exam provided that they have sufficient knowledge in the area of medical devices and pharmaceuticals regulations. Individuals having designations like Pharmacist, Regulatory Scientist, Medical Device Regulatory Specialist, etc. may also apply. The RAC-US exam dumps say that Senior managers with the ability to make recommendations for a particular company's products and services are also eligible to take the exam. Chat with us now to learn more about the eligibility requirements and other requirements for this certification exam.
Why RAPS RAC-US Certification Exam is tough to pass?
There are many factors that contribute to the failure of a RAC-US exam. The candidates can easily fix all of these, with the RAC-US exam dumps. Here are some of the reasons for the failure of the RAPS RAC-US Certification exam:
The mismanagement of time: The candidate should plan well to prepare for the RAC-US Certification exam. The candidate should give enough time to study for the RAC-US Certification exam. The intents and purposes should be set before studying for the RAC-US Certification.
Improper practice: The candidates should take the practice exams on a regular basis. Candidates must ensure that they take the practice exams regularly.
Poor learning techniques: The candidates should learn and follow the proper study techniques. The candidates must spend a lot of time studying for the RAC-US Certification exam. Wellbeing crisis can also be a reason for failure. The candidates should be physically fit and have good mental health.
Lack of proper study materials: The candidates must prepare themselves with the help of the proper study materials. The candidate must understand the concepts thoroughly before attempting the exam.
RAPS RAC-US Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Post-Approval and Lifecycle Management | - Marketed product compliance
|
| Topic 2: Strategic Planning | - Regulatory strategy development
|
| Topic 3: Interfacing with Regulatory Agencies | - Regulatory communication and negotiation
|
| Topic 4: Premarketing | - Product development and approval
|
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