The RAC-US exam is the official RAPS exam behind RAPS Regulatory Affairs Certification (RAC) US — passing it earns you the Regulatory Affairs Certification US (RAC-US) certification, a credential positioned at the Professional level. It is built for candidates who want to validate the skills measured by RAPS Regulatory Affairs Certification (RAC) US. Depending on your track, the exam is also linked to the RAC-EU, RAC-Drugs, RAC-Devices and RAC-Global certifications, so one pass can move you toward more than one RAPS credential.

The RAC-US exam presents 100 questions to be completed within 120 minutes. That pace leaves little room for second-guessing: read each question carefully on the first pass, flag the ones you want to revisit, and keep moving instead of stalling on a single item. Before exam day, run at least one full timed session in the TestSimulate desktop or online test engine with a comparable question load — a steady rhythm under the clock is a trainable skill, and it is often what separates a pass from a near miss.

To pass the RAC-US exam you need Scaled score 70 (range 0–99), and the official registration fee is Member: $605 USD; Non-Member: $760 USD (2026 rates). Keep in mind that a failed attempt means paying that fee again in full — retakes are not discounted. Given the cost, self-test before you book: if you can score comfortably above the passing mark on two or three consecutive timed TestSimulate practice tests, your budget is far better spent on the exam itself than on a retake.

Bachelor's + 3 years experience; Master's + 2 years; Doctorate + 1 year; or 10+ years regulatory experience Because RAPS revises its certification programs from time to time, treat this as a starting point rather than the final word. Confirm the current eligibility requirements on the official RAPS exam page before you register.

Registration for the RAC-US exam is handled through the official channels below:

• RAPS RAC Application Portal

Delivery method: Online remote proctored or in-person at authorized testing centers — pick the option that suits you best when booking your slot.

RAPS points RAPS Regulatory Affairs Certification (RAC) US candidates toward the following official courses:

• RAPS Official RAC Preparation Resources
• RAC-US Candidate Guide

Official courses build the foundation; pairing them with the RAC-US practice questions from TestSimulate turns that knowledge into exam-day readiness.

Yes. A free PDF demo of the RAC-US practice questions is available, so you can check the question style and answer quality before spending anything. Every purchase also includes 365 days of free updates — whenever RAPS adjusts the RAPS Regulatory Affairs Certification (RAC) US blueprint, your material is refreshed at no cost during that period. After the first year, you can extend the update service at a 50% discount from your member zone.

TestSimulate backs your purchase with a 100% Money Back Guarantee. If you take the corresponding exam within 60 days of purchase and do not pass, you can claim a full refund by submitting a scanned copy of your exam enrollment slip together with the official Score Report PDF within 2 days of your exam date; approved claims are processed within 7 days. The guarantee applies only to the exam matching your purchase, the candidate name must match the payer name, and it does not cover attempts taken within 3 days of purchase, candidates who downloaded the material but never sat the exam, expired orders, or free materials. If you would rather keep preparing, you can exchange the product for two free exam preparation packages of equal value and keep the update service on your original purchase.

Delivery is instant: your download is available right after payment, and a copy is emailed to you within one minute. If nothing arrives within 2 hours, check your spam folder and contact our support team. There is no limit on the number of computers you can install the software on.

The RAPS Regulatory Affairs Certification (RAC) US syllabus is organized into 4 domains. Among the headline areas are Development and Pre-Market (28%), Submissions and Regulatory Interactions (24%), Post-Market and Compliance (24%). Rather than copying every subtopic here, we keep the complete, current outline in the Exam Topics section above — work through it domain by domain with the TestSimulate RAC-US practice questions so nothing on the blueprint catches you off guard.