RAC Practice Test (Regulatory Affairs)

The RAC Practice Test (Regulatory Affairs) is a free advanced-level, 25-minute skill test from Science of Apps. It tests readiness for the RAPS Regulatory Affairs Certification (RAC-Drugs and RAC-Devices) — drug development and approval pathways, medical device classification and submissions in the US and EU, clinical trial regulation and GCP, quality systems and manufacturing, and post-market surveillance and labelling — written to FDA guidance, EU MDR, ICH guidelines and the RAC exam domains for 2026. Score 70% or more on its 25 questions to earn a verifiable Regulatory Affairs Exam Readiness certificate (SOA-RA). Every question is based on published standards and research — including Development and approval process: drugs (US Food and Drug Administration), ICH E6 Good Clinical Practice (ICH), Regulation (EU) 2017/745 on medical devices (MDR) (European Union) — and each answer is explained with its source.

Yes. Science of Apps has a free RAC Practice Test built on the current RAPS exam outline for 2026 and 2027. It covers drug and device pathways, FDA and EU MDR submissions, and clinical trials, scores you instantly and issues a verifiable certificate.

Read the five skill areas on this page, then take the 25-minute test online — no fee, course or sign-up. You see every answer explained when you finish. Score 70% or more and you get a Regulatory Affairs Exam Readiness certificate straight away, on screen, as a PDF and by email, with a credential ID anyone can verify.

Yes. The questions are original scenarios written by Science of Apps, and each one is based on a public source you can read: Development and approval process: drugs (US Food and Drug Administration); ICH E6 Good Clinical Practice (ICH); Regulation (EU) 2017/745 on medical devices (MDR) (European Union); Premarket submissions: selecting and preparing the correct submission (US Food and Drug Administration); Current Good Manufacturing Practice (CGMP) regulations (US Food and Drug Administration); Quality Management System Regulation (21 CFR 820, aligned with ISO 13485) (US Food and Drug Administration). The source is shown under each question and linked in the answer review. Science of Apps doesn't copy questions from other tests.

Five skill areas with five questions each, drawn from a bank of 10 per area so a retake brings new questions: Drug Development and Approval Pathways (IND and NDA, Generics and biologics and Expedited programmes); Medical Device Classification and Submissions (US pathways, EU MDR and Software and UDI); Clinical Trials and Good Clinical Practice (GCP, Ethics and consent and Trial conduct); Quality Systems and Manufacturing (GMP, Device QMS and CAPA and inspections); Post-Market Surveillance, Labelling and Compliance (Pharmacovigilance, Device reporting and Labelling and recalls). Every question is an original scenario written to the 2026–2027 standard, with the published source named under it.

Regulatory affairs specialist, Regulatory affairs manager, Quality and compliance professional, Clinical research associate and Medical device engineer. It suits anyone who wants a quick, verifiable way to show RAC knowledge in 2026 and 2027, from students and career switchers to experienced professionals.

RAPS offers RAC-Drugs and RAC-Devices exams, each a proctored, computer-based test of about 100 scored multiple-choice questions covering the product lifecycle globally, with emphasis on major markets like the US and EU.

Regulatory professionals with a few years' experience. RAPS recommends a mix of education and regulatory work experience, and the credential is maintained with continuing education every three years.

No. It is an independent practice test written to the publicly available RAC content outline for 2026 and 2027, for checking your readiness before you book the real exam. Passing earns a Science of Apps certificate rather than the official credential.

Yes. The test is online, in English and free everywhere — people take it from India, the US, the UK, Europe, Africa, Latin America and Asia-Pacific. Your certificate is dated with your own local date and can be verified from anywhere at scienceofapps.com/certification/verify/.

25 questions — 5 from each of 5 skill areas — with a 25-minute limit. You need 70% (18 of 25) to pass and 90% for distinction.

We rate it Advanced: assumes years in the role or deep specialist knowledge. It has 25 scenario questions — 5 from each of 5 skill areas — and a 25-minute limit. You need 70% (18 of 25) to pass and 90% for distinction.

Nothing. There is no fee to take a test, to receive the certificate, to have it emailed or to verify it, and no sign-up.

On our server, not in your browser. The answers never reach the page until you submit, so a certificate can only be earned by passing. Each certificate gets a unique credential ID stored by Science of Apps.

You see your score for each area and every question with the correct answer and why, with the published source behind it. You can retake after 30 minutes, and the retake draws questions you haven't seen yet.

No. Every certificate is dated, so it always shows when you passed. Retake a test any time for a newer date or a higher score.

Yes. After you pass, Add to LinkedIn opens the Licenses & certifications form with the certificate name, Science of Apps as the issuer, the issue date, your credential ID and the verification link filled in. You can also download it as a PDF or PNG, and it's emailed to you as a PDF.

Every certificate has a credential ID and a QR code. Scanning it, or entering the ID at scienceofapps.com/certification/verify/, shows the holder's name, the certification, the score and the issue date from our records.

No. They are Science of Apps' own assessments of applied skill. They aren't issued by a university or standards body, and they work best alongside a portfolio that shows the skills in real work.