Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Russia
EAEU & Russia–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 Russian Federation and the EAEU market.
Our DMF services are designed to meet the expectations of the Ministry of Health of the Russian Federation (MoH RF) and Roszdravnadzor, and align with:
• Federal Law No. 61-FZ “On Circulation of Medicines” – Russia
• EAEU Rules for Registration & Examination of Medicinal Products
• Expert Institution Guidelines (Scientific Centre for Expert Evaluation of Medicinal Products – SCEEMP)
• WHO GMP & EAEU GMP Standards
• ICH Guidelines
• EAEU CTD-based documentation formats
Used for:
• API registration
• Finished formulation product registration
• Import authorization dossiers
• Export-oriented regulatory filings
• EAEU mutual recognition & centralized procedures (Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan)
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Closed Part (Restricted / Confidential Part)
Ensuring full regulatory compliance, confidentiality, and smooth approval processing in Russia and across the EAEU region.
Our Core DMF Services – Russia
🧪 DMF Preparation – Open & Closed Parts (Russia & EAEU-Compliant)
We prepare complete, structured, and MoH RF / EAEU-aligned DMF dossiers following EAEU CTD format accepted for Russian submissions.
Applicant’s Part (Open Part)
Prepared for submission to MoH RF / SCEEMP / Local Marketing Authorization Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6 & EAEU requirements
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– Product registration
– Import authorization
– Marketing authorization
– EAEU mutual recognition procedures
• EAEU CTD-structured documentation suitable for Russia and all EAEU member states
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 & EAEU requirements)
• Control strategy and pharmaceutical quality systems
• Stability data as per EAEU Climatic Zones (Zone II & IVa applicable to Russia)
✅ Confidential information is disclosed only to MoH RF / SCEEMP / EAEU assessors and never to applicants.
DMF Types Covered – Russia
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 – Russia
Already have a DMF for Russia or the EAEU?
We conduct Russia/EAEU-specific DMF review and risk assessment based on:
• MoH RF / SCEEMP expert assessment expectations
• WHO GMP & EAEU GMP compliance gaps
• EAEU CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely EAEU expert deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission.
🧪 MoH RF / EAEU Submission & Russia Regulatory Support
We provide hands-on regulatory support including:
• Ministry of Health & SCEEMP submissions and expert clarifications
• API registration support
• Import authorization dossier preparation
• Finished product registration documentation
• EAEU mutual recognition & regional DMF strategy
Our team ensures:
• Correct EAEU CTD formatting
• Accurate technical cross-referencing
• Full consistency across DMF, product dossiers, and GMP documentation
🧪 DMF Lifecycle Management & Maintenance – Russia
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
• MoH RF / EAEU-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – Russia / EAEU
Complete post-submission regulatory support, including:
• MoH RF / EAEU deficiency letters and expert queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and EAEU authorities
🎯 Goal: Faster approvals, fewer queries, and regulator-ready EAEU DMF documentation.
🧪 Why Choose DMF Direct for Russia?
🧪 In-depth knowledge of MoH RF, SCEEMP & EAEU regulatory pathways
🧪 Strong expertise in WHO GMP, EAEU GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Proven success in EAEU expert deficiency responses
🧪 Seamless coordination with Russian importers & MA holders
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Russia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Russia
• Federal Law No. 61-FZ – On Circulation of Medicines
• Ministry of Health of the Russian Federation Guidelines
• SCEEMP Expert Rules
• WHO GMP & EAEU GMP
• ICH Q-Series & M-Series Guidelines
• EAEU CTD / eCTD-ready documentation
Your Trusted Partner for DMF Excellence in Russia
Whether you are preparing a new DMF, updating an existing dossier, supporting a Ministry of Health / EAEU submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Russian and EAEU pharmaceutical markets.
✅ EAEU Regulatory-aligned
✅ Highly Confidential
✅ Technically Robust
✅ Approval-driven