Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Belarus
Ministry of Health–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 regulatory framework of the Republic of Belarus.
Our DMF services are designed to meet the expectations of the Ministry of Health of the Republic of Belarus and its expert body, the Center for Expertise and Testing in Health Care (CETH), and align with:
• Law on Medicinal Products of the Republic of Belarus
• CETH / Ministry of Health Registration Guidelines
• EAEU (Eurasian Economic Union) Harmonized Rules
• WHO GMP Standards
• ICH Guidelines
• CTD / EAEU CTD-based documentation formats
Used for:
• API registration
• Finished formulation product registration
• Import authorization dossiers
• Export-oriented regulatory filings
• EAEU-linked mutual recognition procedures (where applicable)
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring regulatory compliance, confidentiality, and smooth approval processing in Belarus.
Our Core DMF Services – Belarus
🧪 DMF Preparation – Open & Closed Parts (Belarus-Compliant)
We prepare complete, structured, and Belarus Ministry of Health–aligned DMF dossiers following CTD / EAEU format accepted for Belarus submissions.
Applicant’s Part (Open Part)
Prepared for submission to the Ministry of Health of Belarus / CETH / Local Marketing Authorization Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Product registration
– Import authorization
– Marketing authorization
• CTD-structured documentation suitable for Belarus and the EAEU market
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process and validated process flow diagrams
• Critical process parameters and in-process controls
• Raw material, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality systems
• Stability data as per EAEU climatic requirements (Zone II & IVa where applicable)
✅ Confidential information is disclosed only to Belarus regulators and expert evaluators, not applicants.
DMF Types Covered – Belarus
We support DMF documentation for:
• Type II – Active Pharmaceutical Ingredient (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Belarus
Already have a DMF for Belarus?
We conduct Belarus-specific DMF review and risk assessment based on:
• CETH expert review expectations and audit observations
• WHO GMP & EAEU GMP compliance gaps
• CTD / EAEU CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely Belarus expert deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 Belarus Submission & Regulatory Support
We provide hands-on support for DMF usage and filing in Belarus, including:
• Ministry of Health / CETH submissions and technical clarifications
• API registration support
• Import authorization dossier preparation
• Finished product registration documentation
• EAEU-linked DMF alignment and regional strategy
Our team ensures:
• Correct CTD / EAEU CTD formatting
• Accurate technical cross-referencing
• Full consistency across DMF, product dossiers, and manufacturing documents
🧪 DMF Lifecycle Management & Maintenance – Belarus
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Variations, updates, and renewals
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (accelerated & long-term)
• Specification and analytical method revisions
• Ministry of Health / CETH-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – Belarus
Complete post-submission regulatory support, including:
• CETH deficiency letters and expert queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and Belarus authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Belarus?
🧪 In-depth knowledge of Belarus Ministry of Health & EAEU regulatory pathways
🧪 Strong expertise in WHO GMP, EAEU GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Proven experience in regulatory deficiency responses
🧪 Seamless coordination with Belarusian importers & MA holders
🧪 Supported by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Belarus
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Belarus
• Law on Medicinal Products – Republic of Belarus
• Ministry of Health of Belarus Guidelines
• Center for Expertise and Testing in Health Care (CETH) Rules
• WHO GMP & EAEU GMP
• ICH Q-Series & M-Series Guidelines
• CTD / EAEU CTD-ready documentation
Your Trusted Partner for DMF Excellence in Belarus
Whether you are preparing a new DMF, updating an existing dossier, supporting a Belarus Ministry of Health submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Belarus pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven