RAC-Drugs & RAC-Devices
The RAC, awarded by the Regulatory Affairs Professionals Society (RAPS), is the leading global credential for regulatory affairs professionals in the pharmaceutical and medical device industries. It is the only post-academic professional certification specifically for the regulatory profession, and hiring managers at pharma and medtech employers increasingly list it as a differentiator on senior regulatory job postings. Whether you sit RAC-Drugs or RAC-Devices, the exam tests how you apply FDA, EMA, ICH, and global requirements across a product's life cycle — and this page lays out exactly what each exam covers, how it is delivered, and how to pass it on the first attempt.
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The RAC is offered as two separate exams — choose the product class that matches your career
| Designation | Code | Product scope | Regulatory anchors |
|---|---|---|---|
| RAC (Pharmaceuticals) | RAC-Drugs | Small molecules, biologics, and related products | FDA, EMA, ICH (Q/S/E/M), GMP, pharmacovigilance |
| RAC (Medical Devices) | RAC-Devices | Medical devices and combination products | FDA 510(k)/PMA, EU MDR, design controls, post-market |
You register and sit one designation at a time. Many regulatory professionals working across both pharma and medtech eventually hold both — earning the second RAC by passing its own 120-question exam. Both designations share the same exam length, delivery channels, and three-year recertification cycle.
How the RAC exam is built — at a glance
120
From the Spring 2026 window the exam expanded from 100 to 120 multiple-choice items, including a number of unscored pretest questions that do not count toward your result.
2.5h
Two and a half hours of testing time, also expanded from two hours in the 2026 revision to accommodate the larger item count and more application-style scenarios.
3
Recall, application, and analysis items. A large share are scenario-based, asking you to choose the correct regulatory action rather than recite a single fact.
The 2026 content revision reorganized and renamed the domains and refreshed roughly 5% of items to reflect current regulations. Professional ethics is no longer a standalone scored domain — it is woven through every domain as required underlying knowledge, so you can be tested on it inside any question.
RAPS reports a scaled score, with the passing standard fixed by a formal cut-score (standard-setting) study rather than a flat percentage. Because the scale is equated across forms, you cannot back-calculate how many raw questions you answered correctly. There is no published pass percentage — you receive a pass/fail decision plus a scaled score.
RAC-Drugs domains — bars show each domain's approximate share of the exam (RAC-Devices weights differ)
Evaluating the regulatory environment and advising the business across the product life cycle — from concept and development pathway selection to regulatory intelligence and risk-based strategy.
The largest domain: nonclinical (GLP, toxicology) and clinical development requirements, manufacturing and GMP compliance, and assembling marketing applications such as NDAs, BLAs, and INDs.
Labeling and promotion review, lifecycle changes and variations, pharmacovigilance and safety reporting, and maintaining compliance once a product is on the market.
Communicating and negotiating with health authorities, managing meetings and submissions, and coordinating across cross-functional teams during the regulatory process.
Domain weights are approximate (RAPS notes ±2%). The RAC-Devices exam uses its own four domains — Strategic Planning, Design and Development, the Process for Licensing/Registration/Renewals, and Post-Market Activities — each weighted roughly 23–27%. Always confirm against the current RAPS content outline for your designation before you sit.
Two ways to sit the RAC — and what to expect on test day
You sit the RAC in a quiet, monitored Pearson VUE center. Staff verify your government-issued ID, store your belongings, and watch the room throughout. You schedule a specific date and time within your testing window from the available center slots near you.
You take the RAC from a private, qualifying location using OnVUE remote proctoring. Before the exam unlocks you run a system test, complete a webcam room scan, and pass an ID check. A proctor monitors the entire session. No scratch paper, second monitor, or phone is permitted.
OnVUE blocks corporate VPNs, firewalls, and many work laptops. Run the official system check days in advance on the exact device and network you will use on test day.
A valid, unexpired government photo ID with a name matching your RAPS registration. A clear desk, no notes, and a 360° room scan are required before the exam starts.
Stay in frame and on-camera the whole time. Leaving the seat, talking aloud, or a dropped connection can flag or void the OnVUE session, so a stable wired connection is strongly advised.
The RAC is built for working regulatory professionals
The RAC requires real regulatory experience — and rewards it
Difficulty: The RAC is hard not because of trick wording but because of breadth. You are tested on FDA, EMA, ICH, and global frameworks at once, and the application-style scenarios reward judgment that years of narrow, single-region experience may not have built. Candidates routinely underestimate the pre-marketing domain and the way ethics is now embedded everywhere — exactly the pressure points our help is designed to relieve.
The RAC is a broad, experience-gated exam with a $605+ fee and a registration window you do not want to waste. Exam Assist pairs you with a vetted regulatory affairs specialist and works on a pay-after-you-pass model — so the risk sits with us, not you. No upfront fee, guaranteed results: Exam Assist handles the sitting end to end, and you settle only after the verified result.
Tell us whether you are sitting RAC-Drugs or RAC-Devices, your delivery method (center or OnVUE), and your testing window. Takes a couple of minutes over WhatsApp, Telegram, or Discord.
We review your designation, timeline, and OnVUE setup and tell you plainly whether it is realistic — before any money is discussed. If it is not a fit, we say so.
Exam Assist handles the sitting end to end. You are matched with a regulatory specialist who maps the work around the heavy pre-marketing domain, the embedded ethics items, and the OnVUE environment — discreetly and confidentially.
You only pay once your passing result is confirmed. No verified pass, nothing owed.
Discreet, experience-gated certification support on a pay-after-you-pass basis — built for working professionals like RAC candidates.
ServiceGuidance for remote-proctored exams like Pearson VUE OnVUE — system checks, environment setup, and what trips candidates up.
ServiceBrowse the full range of pay-after-you-pass exam assistance across certifications, admissions, and licensure.
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Straight answers about the RAPS RAC exam
Sibling healthcare and professional certifications
The HCCA's compliance credential — a close cousin of RAC for professionals managing healthcare regulatory risk.
View exam CISAISACA's audit and compliance credential — another experience-gated, globally recognized professional exam.
View exam PMPPMI's flagship credential — like RAC, it gates senior roles and requires documented professional experience.
View examGet expert RAC help with no upfront fee — you settle only after your verified passing result. Honest feasibility answer first, results-first arrangement always.