Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Canada
Health Canada–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for the Canadian regulatory framework.
Our DMF services are designed to meet the expectations of Health Canada—including the Therapeutic Products Directorate (TPD) and Biologic and Radiopharmaceutical Drugs Directorate (BRDD)—and fully align with:
• Food and Drugs Act & Food and Drug Regulations (Canada)
• Good Manufacturing Practices (Division 2, Part C)
• ICH Guidelines (Q, M & E Series)
• Electronic Common Technical Document (eCTD) submissions used for:
• API registration & referencing
• New Drug Submissions (NDS)
• Abbreviated New Drug Submissions (ANDS – Generics)
• Clinical Trial Applications (CTA)
• Importation & Drug Establishment Licensing (DEL) support
• Global export-oriented regulatory filings
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth Health Canada review and approval processing.
Our Core DMF Services – Canada
🧪 DMF Preparation – Open & Closed Parts (Health Canada–Compliant)
We prepare complete, structured, and Health Canada–aligned DMF dossiers strictly following the Canadian DMF format and eCTD structure.
Applicant’s Part (Open Part)
Prepared for submission to Health Canada / ANDS & NDS Applicants / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– New Drug Submission (NDS)
– Abbreviated New Drug Submission (ANDS)
– Clinical Trial Application (CTA)
– Drug Establishment License (DEL)
• eCTD-ready documentation suitable for Canada and global markets
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process & flow diagrams
• Critical process parameters (CPPs) & in-process controls (IPCs)
• Raw material, intermediate & finished product specifications
• Analytical methods & method validation (ICH Q2(R2))
• Control strategy & Pharmaceutical Quality System (ICH Q10)
• Stability data as per Canada climatic zone requirements (Zone II & IVa/IVb, as applicable)
✅ Confidential information is disclosed only to Health Canada and is never shared with applicants.
Health Canada Master File Types Covered
We support preparation and maintenance of all official Health Canada Master File (MF) Types:
• Type II – Drug Substance (API), Drug Product & Intermediates
• Type III – Packaging Materials
• Type IV – Excipients, Colors, Flavors
• Type V – Reference Information (Unique Manufacturing Data)
🧪 DMF Review & Gap Assessment – Canada
Already have a Canadian Master File (MF)?
We conduct a Canada-specific MF/DMF review and regulatory risk assessment based on:
• Health Canada current expectations & inspection trends
• GMP, DEL & ICH compliance gaps
• eCTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely Health Canada Screening Deficiency Letter (SDL) & Clarification Request triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 Health Canada Submission & Regulatory Support
We provide hands-on support for DMF/MF filing and usage with Health Canada, including:
• New Master File submissions (eCTD format)
• Letters of Access (LoA) preparation
• ANDS / NDS / CTA cross-referencing
• Drug Establishment License (DEL) technical support
• Importation & site licensing documentation
• Global export-linked Health Canada alignment
Our team ensures:
• Correct eCTD formatting
• Accurate cross-referencing via LoAs
• Full consistency across MF, ANDS/NDS, and site records
🧪 DMF Lifecycle Management & Maintenance – Canada
We manage your DMF/MF throughout its complete regulatory lifecycle with Health Canada, including:
• Initial MF compilation & submission
• Annual updates & Letters of Continued Access (LCA)
• Manufacturing site changes & supplements
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• Health Canada-driven amendments and deficiency updates
🧪 Post-Submission Deficiency & Query Handling – Health Canada
Complete post-submission regulatory support for Canadian Master Files, including:
• Health Canada screening deficiencies & technical queries
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with ANDS/NDS applicants
• Coordination between manufacturer, sponsor, and Health Canada
🎯 Goal: Faster approvals, zero-defect submissions, and regulator-ready Master Files for the Canadian market.
🧪 Why Choose DMF Direct for Canada?
🧪 In-depth knowledge of Health Canada MF, ANDS & NDS pathways
🧪 Expertise in Canadian GMP, DEL & ICH requirements
🧪 Secure handling of high-value confidential manufacturing data
🧪 Strong Health Canada deficiency response experience
🧪 Seamless coordination with Canadian applicants, sponsors & license holders
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Canada
• Global API manufacturers
• Finished dosage form (FDF) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• Canadian importers & CMOs
• Drug development & biotech companies
• ANDS / NDS sponsor companies
Regulatory Standards Followed – Canada
• Food and Drugs Act & Food and Drug Regulations (Canada)
• Health Canada GMP (Division 2)
• Drug Establishment Licensing (DEL) Requirements
• ICH Q-Series, M-Series & E-Series Guidelines
• eCTD Module 2 & Module 3 Documentation
• WHO & Health Canada Technical Reports
Your Trusted Partner for DMF Excellence in Canada
Whether you are preparing a new Health Canada Master File, supporting an ANDS / NDS submission, responding to screening deficiencies, or managing MF lifecycle updates, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Canadian pharmaceutical market.
✅ Health Canada–aligned
✅ Fully confidential
✅ eCTD-ready
✅ Approval-driven