Drug Regulatory Affairs Course
Gain expertise in drug regulatory affairs for pharmacy. Master US and EU approval pathways, CTD/eCTD dossier preparation, CMC and bioequivalence needs, labelling standards, inspection preparation, and post-approval responsibilities to confidently deliver safe, compliant drugs to market.

from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
This course equips you with hands-on skills to handle US and EU drug submissions, select ideal pathways, and create compliant CTD/eCTD dossiers. You will cover key CMC and bioequivalence topics, post-approval duties, pharmacovigilance, labelling requirements, inspection readiness, and smooth interactions with regulators for quicker approvals and sustained compliance.
Elevify advantages
Develop skills
- Design US/EU generic pathways by selecting the best FDA or EMA route quickly.
- Build strong CMC packages with quality, stability, and bioequivalence study data.
- Compile CTD/eCTD dossiers by structuring Modules 1 to 5 for smooth approvals.
- Handle interactions with agencies by confidently responding to FDA/EMA queries.
- Manage post-approval tasks including pharmacovigilance, variations, labelling, and safety updates.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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