Regulatory Affairs is the discipline that connects product innovation in FDA-regulated industries to market access and patient safety. Every medical-device, pharmaceutical, biologic, food, and cosmetic company operates inside a national and international regulatory framework, and every such company needs professionals who command that framework with fluency. For career-changers entering Regulatory Affairs from engineering, science, clinical, law, quality, or pharmacy backgrounds, the first step is to build a structured foundation of vocabulary, frameworks, and regulatory pathways — and that is exactly what this course does.

This 16-hour Professional Certificate Course is the entry point of the Aleph Introduction to Regulatory Affairs course track and the gateway course of the broader Aleph regulatory portfolio. It introduces the regulatory environment: the role of the U.S. FDA (CDER, CBER, CDRH, CFSAN, CVM, CTP) under the Federal Food, Drug, and Cosmetic Act; the European framework (EMA, EU MDR, EU IVDR, national competent authorities); the principal medical-device premarket pathways (510(k), De Novo, PMA, HDE, IDE) and pharmaceutical pathways (IND, NDA, ANDA, BLA); the harmonization frameworks (ICH for pharmaceuticals, IMDRF for devices); the principal quality frameworks (ISO 13485, ICH Q10); the risk-management frameworks (ISO 14971, ICH Q9); the labeling, advertising, and promotion frameworks; and the other major regulatory markets (Canada, Japan, China). It establishes the vocabulary, the citation discipline, and the regulatory reasoning the entire Aleph regulatory course portfolio builds on.

The course prepares participants for the Advanced level (`RAQ-500-A`), where the same content is exercised at applied depth — comparative pathway analysis, applied ICH and IMDRF harmonization work, applied labeling and promotion analysis, and a preliminary regulatory-strategy construction exercise. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the regulatory vocabulary and framework the regulated industries expect of someone entering the Regulatory Affairs profession. Employers in this space include medical-device manufacturers across all categories, pharmaceutical and biotechnology companies, food and dietary-supplement companies, cosmetics companies, contract manufacturing and contract research organizations, and the consultancies that serve all of these. The Introductory level is the gateway course to the Aleph regulatory portfolio and the right starting point for anyone entering the profession.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.