— Course series

Regulatory Affairs - Global Foundations Certification

Regulatory Affairs — Global Foundations
The regulatory toolkit every pharma professional needs.
Learn the frameworks that govern drug development worldwide — FDA, EMA, ICH guidelines, CTD/eCTD submissions, lifecycle management, and post-marketing surveillance. The essential foundation before specializing in any region.
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15 modules

Comprehensive, self-paced curriculum covering every core competency.

CPD-certified

Accredited programs recognized by sponsors, CROs, and health authorities.

10 Expert instructors

Direct access to working CRAs and CRCs who guide your real-world growth.

12 months access

Full year of platform access from enrollment — learn on your schedule.
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— What's included

Build a global regulatory career

CPD-certified training in pharmaceutical regulatory affairs across the world's major markets — from ICH guidelines and the CTD/eCTD to FDA, EMA, and PMDA submissions, biologics, devices, and pharmacovigilance.

  • Global submission pathwaysInteractive video

    Fifteen modules on the CTD/eCTD, IND/CTA, NDA/BLA/MAA, lifecycle variations, biologics and biosimilars, medical devices, and modern regulatory writing.

  • ICH guidelines & regulatory strategy

    Apply ICH E6, E8, M4, and the Q-series across global submissions — and learn the strategic toolkit (TPP, accelerated pathways, scientific advice) that wins approvals.

  • Submission-Ready Regulatory Skills

    Build the CTD/eCTD, IND/IMPD, and global submission skills sponsors hire for — mapped to FDA, EMA, ICH M4, and Health Canada submission expectations.

Course Curriculum

Bundle offer