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FDA, EMA, ICH Compliance Training

FDA, EMA, ICH Compliance Training

About This Course
Become a certified Regulatory Affairs expert for pharma, biotech & medical devices .
Master global regulations: FDA, EMA, ICH, CDSCO .
Learn drug development, IND/NDA/ANDA submissions, GMP compliance, labeling & pharmacovigilance .
Get hands-on with eCTD software, dossier compilation & regulatory audits .
Flexible 3–6 month online program for graduates & professionals .
Gain practical skills with real-world case studies & capstone project .
Fast-track your career & secure high-paying global Regulatory Affairs roles .
Expert-led training with job readiness & interview preparation support .
What You'll Learn
  • Understand regulatory affairs basics, global scope & career paths.
  • Learn drug development lifecycle & clinical trial phases I–IV.
  • Explore global agencies – FDA, EMA, CDSCO & ICH guidelines.
  • Master regulatory submissions – IND, NDA, ANDA, CTD/eCTD.
  • Study quality systems – GMP, GLP, GCP, GDP, audits, SOPs.
  • Know labeling, packaging rules & advertising compliance.
  • Get insights on medical devices, 510(k), PMA & CE Marking.
  • Learn biologics & biosimilars regulatory pathways.
  • Understand regulations in India, China, Brazil & more.
  • Gain pharmacovigilance skills – ADRs, PSURs, RMPs.
  • Use eCTD tools, RIMS & manage digital submissions.
  • Capstone – compile dossiers, mock audits, resume & job prep.
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