Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Armenia
Armenian MoH & ARMDRUGEXPERT-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 Armenia’s regulatory framework.
Our DMF services are designed to meet the expectations of the:
• Ministry of Health (MoH), Republic of Armenia
• Scientific Center of Drug and Medical Technology Expertise (ARMDRUGEXPERT)
And align with:
• Law on Medicines of the Republic of Armenia
• Armenian GMP (harmonized with EAEU & WHO standards)
• ICH Guidelines
• CTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) approvals
• Import registration 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 full regulatory compliance, strict confidentiality, and smooth approval processing in Armenia.
Our Core DMF Services – Armenia
🧪 DMF Preparation – Open & Closed Parts (Armenia-Compliant)
We prepare complete, structured, and ARMDRUGEXPERT-aligned DMF dossiers strictly following the CTD format accepted for Armenian submissions.
Applicant’s Part (Open Part)
Prepared for submission to ARMDRUGEXPERT / Local Marketing Authorization Holders (MAH) / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– State Registration of Medicines
– Import Permit
– Manufacturing & GMP Certification
• CTD-structured documentation suitable for Armenia and EAEU markets
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process & process flow diagrams
• Critical process parameters (CPPs) & in-process controls (IPCs)
• Raw materials, intermediates & finished product specifications
• Analytical methods & method validation (ICH Q2(R2))
• Control strategy & pharmaceutical quality system (PQS)
• Stability data as per Armenia climatic conditions (Zone II)
✅ Confidential data is disclosed only to ARMDRUGEXPERT regulators and is never shared with applicants or third parties.
DMF Types Covered – Armenia
We support CTD-based DMF documentation for:
• Type II – Active Pharmaceutical Ingredients (API), Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF Review & Gap Assessment – Armenia
Already have a DMF for Armenia?
We conduct an Armenia-specific DMF review and regulatory risk assessment based on:
• ARMDRUGEXPERT expectations and regulatory observations
• Armenian GMP & EAEU-GMP compliance gaps
• CTD structure and technical content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely ARMDRUGEXPERT deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission or inspection.
🧪 ARMDRUGEXPERT Submission & Armenia Regulatory Support
We provide hands-on support for DMF usage and registration filing in Armenia, including:
• ARMDRUGEXPERT submissions and regulatory clarifications
• API registration support
• Import registration dossiers
• GMP & manufacturing documentation
• Export-linked DMF alignment
Our team ensures:
• Correct CTD formatting
• Accurate cross-referencing
• Full consistency across DMF, state registration dossier, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Armenia
We manage your DMF throughout its complete regulatory lifecycle in Armenia, including:
• Initial DMF compilation
• Annual updates & variation filings
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• ARMDRUGEXPERT-driven variations and compliance updates
🧪 Post-Submission Deficiency & Query Handling – ARMDRUGEXPERT
Complete post-submission regulatory support for Armenia, including:
• ARMDRUGEXPERT deficiency letters & technical queries
• Scientific justification & deficiency response drafting
• Revised Open & Closed Part submissions
• Alignment with MAH / local applicant responses
• Coordination between manufacturer, MAH, and ARMDRUGEXPERT
🎯 Goal: Faster approvals, fewer regulatory queries, and authority-ready DMF documentation.
🧪 Why Choose DMF Direct for Armenia?
🧪 In-depth knowledge of Armenia MoH & ARMDRUGEXPERT regulatory pathways
🧪 Expertise in Armenian GMP, EAEU-GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing data
🧪 Strong ARMDRUGEXPERT deficiency response experience
🧪 Seamless coordination with Armenian MAHs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Armenia
• API manufacturers
• Finished formulation manufacturers (FPP)
• Excipient manufacturers
• Packaging material suppliers
• Importers & exporters
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Armenia
• Law on Medicines – Republic of Armenia
• ARMDRUGEXPERT & MoH Guidelines
• Armenian GMP (EAEU & WHO aligned)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO & EAEU Technical Reports
Your Trusted Partner for DMF Excellence in Armenia
Whether you are preparing a new DMF, updating an existing dossier, supporting an ARMDRUGEXPERT submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Armenian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven