Health Canada Master Files (MFs) are a powerful tool for protecting proprietary information while streamlining regulatory submissions — but navigating their requirements can be complex. Understanding how to prepare, submit, and maintain a compliant Master File is essential to safeguard intellectual property, avoid costly delays, and accelerate product approvals in Canada’s competitive pharmaceutical product market.
In this webinar, you’ll gain clear, actionable guidance on:
1. Master File Fundamentals – Definition, purpose, and the confidentiality advantage
2. Global Acceptance – Which agencies accept Master Files
3. Documentation Essentials – Administrative & quality requirements, Restricted vs. Applicant’s Part
4. Cost Breakdown – Health Canada user fees and budgeting insights
5. Submission Best Practices – Electronic formats, ESG NextGen secure gateway, and eCTD benefits
6. Registrar Corp Support – Expert MF preparation, secure communication, and MyFDA portal tools
Conclude with an interactive Q&A session, where our experts will address your submission challenges and share practical resources to help you navigate the Health Canada Master File process with confidence
 
      