Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Georgia
SRAMPA Georgia–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 Georgia’s regulatory framework.
Our DMF services are designed to meet the expectations of the State Regulation Agency for Medical and Pharmaceutical Activities (SRAMPA), Ministry of Internally Displaced Persons, Labour, Health and Social Affairs, Georgia, and align with:
• Law on Medicinal Products and Pharmaceutical Activities – Georgia
• SRAMPA Guidelines for Registration of Medicinal Products
• WHO GMP Standards
• ICH Guidelines
• CTD-based documentation formats
• EU/CIS-aligned regulatory practices (Georgia reference jurisdictions supported)
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 Georgia.
Our Core DMF Services – Georgia
🧪 DMF Preparation – Open & Closed Parts (Georgia-Compliant)
We prepare complete, structured, and SRAMPA-aligned DMF dossiers following CTD format accepted for Georgian submissions.
Applicant’s Part (Open Part)
Prepared for submission to SRAMPA Georgia / 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 Georgia and regional CIS markets
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)
• Control strategy and pharmaceutical quality systems
• Stability data as per WHO Climatic Zone II / IVa (as applicable for Georgia)
✅ Confidential information is shared only with SRAMPA regulators and never with applicants.
DMF Types Covered – Georgia
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 – Georgia
Already have a DMF for Georgia?
We conduct Georgia-specific DMF review and risk assessment based on:
• SRAMPA regulatory expectations and expert assessment remarks
• WHO GMP compliance gaps
• CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely SRAMPA technical deficiency triggers
✔️ You receive a clear, actionable gap assessment report prior to submission.
🧪 SRAMPA Submission & Georgia Regulatory Support
We provide hands-on support for DMF usage and filing in Georgia, including:
• SRAMPA 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 – Georgia
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
• SRAMPA-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – SRAMPA Georgia
Complete post-submission regulatory support, including:
• SRAMPA deficiency letters and expert queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with applicant responses
• Coordination between manufacturer, importer, and SRAMPA authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready DMF documentation.
🧪 Why Choose DMF Direct for Georgia?
🧪 In-depth knowledge of SRAMPA & 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 Georgian importers & MA holders
🧪 Supported by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Georgia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers and distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Georgia
• Law on Medicinal Products – Georgia
• SRAMPA Georgia Guidelines
• WHO GMP
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• CIS/EU reference technical practices (where applicable)
Your Trusted Partner for DMF Excellence in Georgia
Whether you are preparing a new DMF, updating an existing dossier, supporting a SRAMPA submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Georgian pharmaceutical market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven