Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Cambodia
DDF Cambodia–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 Cambodia’s regulatory framework.
Our DMF services are designed to meet the requirements of the Department of Drugs and Food (DDF), Ministry of Health, Cambodia and comply with:
Law on the Management of Pharmaceuticals of the Kingdom of Cambodia
Prakas & Sub-Decrees of the Ministry of Health
Cambodia GMP Guidelines
ICH Guidelines
CTD-based submissions used for:
• API registration
• Finished formulation approvals
• Import 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 Cambodia.
Our Core DMF Services – Cambodia
🧪 DMF Preparation – Open & Closed Parts (Cambodia-Compliant)
We prepare complete, structured, and DDF-aligned DMF dossiers following the CTD format accepted for Cambodia submissions.
Applicant’s Part (Open Part)
Prepared for submission to DDF Cambodia / Local Applicants / 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 Authorization & Market Approval
• CTD-structured documentation suitable for Cambodia 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 quality assurance systems
• Stability data as per Cambodia climatic conditions (Zone IVb)
✅ Confidential data is disclosed strictly to DDF regulators and never to local applicants or importers.
DMF Types Covered – Cambodia
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 – Cambodia
Already have a DMF for Cambodia?
We conduct Cambodia-specific DMF review and risk assessment based on:
• DDF expectations and inspection practices
• GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely DDF deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 DDF Submission & Cambodia Regulatory Support
We provide hands-on support for DMF usage and filing in Cambodia, including:
• DDF Cambodia submissions and clarifications
• API registration support
• Import authorization dossiers
• Finished product registration support
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Consistency across DMF, registration dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Cambodia
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• DDF-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – DDF Cambodia
Complete post-submission regulatory support for Cambodia, including:
• DDF deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with local applicant responses
• Coordination between manufacturer, importer, and DDF authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Cambodia?
🧪 In-depth knowledge of DDF Cambodia regulatory pathways
🧪 Expertise in Cambodia GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong DDF deficiency response experience
🧪 Seamless coordination with Cambodia importers and applicants
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Cambodia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Cambodia
• Cambodia Law on the Management of Pharmaceuticals
• DDF & MOH Prakas & Guidelines
• Cambodia GMP Regulations
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Cambodia
Whether you are preparing a new DMF, updating an existing dossier, supporting a DDF Cambodia submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Cambodia market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven