How much is the cost for taking the RAPS RAC-US Certification Exam?
The cost for the RAPS RAC-US Certification Exam is 490 USD for members and 615 USD for non-member of the RAPS. Warning! The exam fees should be paid in US dollars only.
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A few advantages of getting the RAPS RAC-US Certification:
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Increased salary: A RAC-US certified professional has an increased chance to get higher pay in their career. Companies that are looking to hire a regulatory affairs professional can consider hiring a RAC-US certified professional. You will be able to get a great advantage when you apply for the job because you have the RAC-US Certification.
Skill & knowledge: You will be trained to handle complex regulatory affairs. Moreover, you will gain experience and expertise to get better opportunities in the regulatory affairs profession. Client expense is also saved due to the reduced turnaround time.
Recognition: The RAC program provides recognition to the individuals who have achieved the certification. The RAC-US Certification also provides job opportunities and recognition to the candidates. The rate of employer sponsorship for this certification is very high. Hence, it is beneficial for all aspiring professionals and candidates.
Career growth: The RAC certification helps you to build a successful career by making you eligible to apply for high-profile positions in the pharmaceutical industry, government agencies, and non-profit organizations.
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RAPS RAC-US Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Quality Systems and Regulatory Operations | - GxP systems (GMP, GCP, GLP) - Inspections and regulatory audits |
| Topic 2: Premarket Requirements | - Labeling and promotional compliance - Marketing authorization pathways (NDA, ANDA, PMA, 510(k)) |
| Topic 3: Product Development Lifecycle | - Clinical trial frameworks and submissions (IND/IDE) - Drug and device development stages |
| Topic 4: Regulatory Foundations | - Regulatory ethics and compliance principles - US regulatory structure and agencies (FDA overview) |
| Topic 5: Postmarket Compliance | - Device vigilance and recalls - Pharmacovigilance and adverse event reporting |
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