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