Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Vietnam
DAV Vietnam–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides comprehensive Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for Vietnam’s pharmaceutical regulatory framework.
Our DMF services are designed to meet the requirements of the Drug Administration of Vietnam (DAV), Ministry of Health (MOH), Vietnam and comply with:
Law on Pharmacy No. 105/2016/QH13
Vietnam MOH Circulars & Drug Registration Guidelines
ASEAN GMP & PIC/S GMP
ICH Guidelines
ASEAN CTD (ACTD) / CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & marketing authorization dossiers
• 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 approval processing in Vietnam.
Our Core DMF Services – Vietnam
🧪 DMF Preparation – Open & Closed Parts (Vietnam-Compliant)
We prepare complete, structured, and DAV-aligned DMF dossiers following the ACTD / CTD format accepted for Vietnam submissions.
Applicant’s Part (Open Part)
Prepared for submission to DAV Vietnam / Local MA Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– API Registration
– Finished Product Registration
– Import License & Marketing Authorization
• ACTD/CTD-structured documentation suitable for Vietnam and global exports
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process and process flow diagrams
• Critical process parameters and in-process controls
• Raw materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality system (PQS)
• Stability data as per Zone IVb climatic conditions applicable to Vietnam
✅ Confidential data is disclosed strictly to DAV regulators and never to local applicants or distributors.
DMF Types Covered – Vietnam
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Vietnam
Already have a DMF for Vietnam?
We conduct Vietnam-specific DMF review and risk assessment based on:
• DAV technical expectations & inspection practices
• ASEAN/PIC/S GMP compliance gaps
• ACTD/CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DAV deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 DAV Submission & Vietnam Regulatory Support
We provide hands-on support for DMF usage and filing in Vietnam, including:
• DAV submissions and clarifications
• API registration support
• Finished product registration support
• Import license & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct ACTD/CTD formatting
• Accurate cross-referencing
• Consistency across DMF, DAV dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Vietnam
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and post-approval variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• DAV-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – DAV Vietnam
Complete post-submission regulatory support for Vietnam, including:
• DAV deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with MA holder responses
• Coordination between manufacturer, MA holder, and DAV authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Vietnam?
🧪 In-depth knowledge of DAV Vietnam regulatory pathways
🧪 Expertise in ASEAN GMP, PIC/S & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong DAV deficiency response experience
🧪 Seamless coordination with Vietnamese MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Vietnam
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Vietnam
• Law on Pharmacy, Vietnam
• Vietnam MOH & DAV Guidelines
• ASEAN GMP & PIC/S GMP
• ICH Q-Series & M-Series Guidelines
• ACTD / CTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Vietnam
Whether you are preparing a new DMF, updating an existing dossier, supporting a Vietnam DAV submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Vietnamese market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven