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