Overview
Canada is a key market often aligned with US development. We help you adapt your US or EU dossier for Health Canada requirements, managing New Drug Submissions (NDS) and Supplemental NDS filings. We understand the nuances of the Food and Drugs Act and Regulations.
Key Features
NDS and SNDS preparation
Canadian-specific Module 1
Product Monograph development
Clarifax response management
Our Process
1
Gap Analysis
Identifying Canadian-specific requirements.
2
Conversion
Adapting the CTD to Health Canada specifications.
3
Submission
Filing via the Common Electronic Submissions Gateway (CESG).
Project Complete & Deliverables Provided
Frequently Asked Questions
Yes, Health Canada participates in several international collaboration initiatives. Through Project Orbis (oncology) and Access Consortium, Health Canada can conduct parallel reviews with FDA, EMA, and other agencies. For standard submissions, they'll consider foreign reviews but still conduct their own assessment. Having FDA or EMA approval strengthens your submission.
Why Choose Us
- Efficient market entry in Canada
- Leveraging of foreign reviews
- Compliance with bilingual requirements
- Strategic launch timing
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Schedule ConsultationWhat Our Clients Say
"We needed Canadian approval within 6 months of our FDA approval. Adelphi prepared our NDS in parallel with our NDA, leveraged Project Orbis for parallel review, and we received our Notice of Compliance just 8 weeks after FDA approval."
Jennifer Walsh
VP Global Regulatory
Oncology Biotech
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