Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Kazakhstan
CMPC Kazakhstan–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 Kazakhstan’s regulatory framework.
Our DMF services are designed to meet the expectations of the Committee for Medical and Pharmaceutical Control (CMPC), Ministry of Health of the Republic of Kazakhstan, and align with:
• Code of the Republic of Kazakhstan on Public Health and Healthcare System
• CMPC / National Center for Expertise of Medicines & Medical Devices (NCEMMD) Guidelines
• EAEU Harmonized Rules for Medicines Registration
• 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 (Kazakhstan, Russia, 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 Kazakhstan and across the EAEU region.
Our Core DMF Services – Kazakhstan
🧪 DMF Preparation – Open & Closed Parts (Kazakhstan-Compliant)
We prepare complete, structured, and CMPC / EAEU-aligned DMF dossiers following EAEU CTD format accepted for Kazakhstan submissions.
Applicant’s Part (Open Part)
Prepared for submission to CMPC / NCEMMD Kazakhstan / 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 Kazakhstan 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, as applicable to Kazakhstan)
✅ Confidential information is disclosed only to CMPC / EAEU assessors and never to applicants.
DMF Types Covered – Kazakhstan
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 – Kazakhstan
Already have a DMF for Kazakhstan or EAEU?
We conduct Kazakhstan/EAEU-specific DMF review and risk assessment based on:
• CMPC & NCEMMD 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 or inspection.
🧪 CMPC / EAEU Submission & Kazakhstan Regulatory Support
We provide hands-on regulatory support including:
• CMPC & NCEMMD Kazakhstan submissions and technical 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 – Kazakhstan
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
• CMPC / EAEU-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – CMPC Kazakhstan / EAEU
Complete post-submission regulatory support, including:
• CMPC / 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 Kazakhstan?
🧪 In-depth knowledge of CMPC, NCEMMD & 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 Kazakh importers & MA holders
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Kazakhstan
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Kazakhstan
• Public Health Code – Republic of Kazakhstan
• CMPC / NCEMMD Kazakhstan Guidelines
• WHO GMP & EAEU GMP
• ICH Q-Series & M-Series Guidelines
• EAEU CTD / eCTD-ready documentation
Your Trusted Partner for DMF Excellence in Kazakhstan
Whether you are preparing a new DMF, updating an existing dossier, supporting a CMPC / EAEU submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Kazakhstan and EAEU pharmaceutical markets.
✅ EAEU Regulatory-aligned
✅ Highly Confidential
✅ Technically Robust
✅ Approval-driven