
All courses
Bring therapies to market
Regulatory Affairs
Submission strategy, eCTD authoring, and life-cycle management across Health Canada, FDA, and EMA — built for the Canadian market.
Duration
10 weeks
Schedule
EST
Certificate
Included
Apply by
June 10, 2026
What you'll learn
- Health Canada NDS / ANDS / SNDS submissions
- eCTD structure and module-3 authoring basics
- FDA 510(k) and IND/NDA pathways
- Labelling, post-market commitments, and life-cycle management
- Regulatory intelligence and agency interaction
Curriculum
Weekly modules with live sessions, recordings, hands-on labs, and 1:1 reviews.
Who this is for
Best for
Strategic thinkers who want to shape how drugs reach patients.
You'll be ready to be
Future RA associates, submissions specialists, and strategy analysts.
Frequently asked
Yes — every live class is recorded and added to your dashboard within 24 hours so you can revisit any topic at your own pace.