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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.

Batch starts

June 17

30 / 30 seats
Apply for this batch

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.