Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Azerbaijan
AEC-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 Azerbaijan’s regulatory framework.
Our DMF services are designed to meet the expectations of the Analytical Expertise Center (AEC), Ministry of Health, Republic of Azerbaijan and align with:
• Law on Medicines of the Republic of Azerbaijan
• AEC Guidelines for Registration of Medicinal Products
• WHO GMP Standards
• ICH Guidelines
• CTD-based documentation formats
• EAEU / CIS-aligned regulatory practices (where applicable)
Used for:
• API registration
• Finished formulation product registration
• Import 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 regulatory compliance, confidentiality, and smooth approval processing in Azerbaijan.
Our Core DMF Services – Azerbaijan
🧪 DMF Preparation – Open & Closed Parts (Azerbaijan-Compliant)
We prepare complete, structured, and AEC-aligned DMF dossiers following CTD format accepted for Azerbaijani submissions.
Applicant’s Part (Open Part)
Prepared for submission to AEC Azerbaijan / 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 Azerbaijan and CIS markets
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 material, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality systems
• Stability data as per WHO Climatic Zone II / IVa (as applicable for Azerbaijan)
✅ Confidential information is shared only with AEC regulators and never with applicants.
DMF Types Covered – Azerbaijan
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 – Azerbaijan
Already have a DMF for Azerbaijan?
We conduct Azerbaijan-specific DMF review and risk assessment based on:
• AEC regulatory expectations and expert review remarks
• WHO GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely AEC technical deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 AEC Submission & Azerbaijan Regulatory Support
We provide hands-on support for DMF usage and filing in Azerbaijan, including:
• AEC submissions and technical clarifications
• API registration support
• Import authorization dossier preparation
• Finished product registration documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate technical cross-referencing
• Full consistency across DMF, product dossiers, and manufacturing documents
🧪 DMF Lifecycle Management & Maintenance – Azerbaijan
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
• AEC-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – AEC Azerbaijan
Complete post-submission regulatory support, including:
• AEC deficiency letters and expert queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and AEC authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Azerbaijan?
🧪 In-depth knowledge of AEC & CIS/Eurasian regulatory pathways
🧪 Strong expertise in WHO GMP and ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Proven experience in regulatory deficiency responses
🧪 Seamless coordination with Azerbaijani importers & MA holders
🧪 Supported by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Azerbaijan
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Azerbaijan
• Law on Medicines – Republic of Azerbaijan
• AEC Azerbaijan Guidelines
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• CIS / EAEU-aligned technical practices (where applicable)
Your Trusted Partner for DMF Excellence in Azerbaijan
Whether you are preparing a new DMF, updating an existing dossier, supporting an AEC submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Azerbaijani pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven