Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Estonia
SAM Estonia–Compliant DMF Documentation & EU 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 Estonia’s EU-regulated pharmaceutical framework.
Our DMF services are designed to meet the expectations of the State Agency of Medicines (SAM), Estonia, and align with:
• EU Directive 2001/83/EC & Regulation (EC) No 726/2004
• Estonian Medicinal Products Act
• EMA & CMDh Guidelines
• EU GMP (EudraLex Volume 4)
• ICH Guidelines
• EU CTD / eCTD format
Used for:
• Active Substance Master File (ASMF / European DMF) submissions
• Finished formulation (FPP) marketing authorization applications
• Import authorization dossiers
• EU export-oriented regulatory filings
• Mutual Recognition & Decentralized Procedures (MRP/DCP)
We specialize in the preparation and maintenance of both:
Applicant’s Part (AP / Open Part)
Restricted Part (RP / Closed / Confidential Part)
Ensuring full EU regulatory compliance, confidentiality, and smooth approval processing in Estonia and across the EU.
Our Core DMF / ASMF Services – Estonia
🧪 ASMF / DMF Preparation – Open & Closed Parts (EU & Estonia-Compliant)
We prepare complete, structured, and SAM & EMA-aligned ASMF/DMF dossiers following the EU CTD structure.
Applicant’s Part (Open Part – AP)
Prepared for submission to SAM Estonia / EMA / EU Applicants / MAHs, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6 & EU requirements
• Non-confidential manufacturing and quality information
• Cross-reference-ready content for:
– National Estonian MA procedures
– Decentralized & Mutual Recognition Procedures (DCP/MRP)
– Centralized EU submissions (where applicable)
• EU CTD-structured documentation suitable for Estonia and all EU member states
Restricted Part (Closed / Confidential Part – RP)
Secure preparation and handling of proprietary active substance information, including:
• Detailed manufacturing process and validated process flow diagrams
• Critical process parameters and in-process controls
• Raw material, intermediates, and active substance specifications
• Analytical methods and method validation (ICH Q2 / EU Pharmacopoeia)
• Control strategy and pharmaceutical quality systems
• Stability data as per ICH Climatic Zone II (applicable to Estonia & EU)
✅ Confidential data is submitted only to SAM/EMA assessors and never shared with applicants.
DMF / ASMF Types Covered – Estonia
We support:
• ASMF (European DMF) – Active Substances
• Type II – APIs & Intermediates
• Type III – Packaging Materials
• Type IV – Excipients
• Type V – Reference / Miscellaneous Information
🧪 DMF / ASMF Review & Gap Assessment – Estonia
Already have a DMF or ASMF for Estonia or the EU?
We conduct Estonia/EU-specific dossier reviews based on:
• SAM & EMA assessment expectations
• EU GMP / EudraLex compliance gaps
• EU CTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely EU Day-120 / Day-210 deficiency triggers
✔️ You receive a clear, regulator-ready gap assessment report before submission.
🧪 SAM / EMA Submission & Estonia Regulatory Support
We provide hands-on EU regulatory support including:
• SAM Estonia submissions & national MA support
• ASMF/DMF linkage support with applicants
• DCP / MRP coordination
• Import authorization dossiers
• EU export-linked DMF alignment
We ensure:
• Correct EU CTD & eCTD formatting
• Accurate technical cross-referencing
• Full consistency across ASMF, MA dossier, and GMP documentation
🧪 DMF / ASMF Lifecycle Management & Maintenance – Estonia
We manage your ASMF throughout its entire lifecycle, including:
• Initial ASMF compilation
• Annual updates
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (long-term & accelerated)
• Specification and analytical method revisions
• EU variation classification (Type IA, IB & II)
🧪 Post-Submission Deficiency & Query Handling – SAM / EMA
Complete post-submission regulatory support including:
• EU assessment questions (Day-120 / Day-180 / Day-210)
• Scientific justification & response writing
• Updated AP & RP submissions
• Applicant alignment and regulator coordination
• EMA / SAM teleconference & review strategy support
🎯 Goal: Faster EU approvals, clean assessment cycles, and regulator-ready ASMF documentation.
🧪 Why Choose DMF Direct for Estonia?
🧪 Deep expertise in EU ASMF & CTD submissions
🧪 Strong command of EMA, CMDh, and SAM regulatory pathways
🧪 Full compliance with EU GMP & ICH standards
🧪 Secure handling of confidential RP data
🧪 Proven success in EU deficiency responses & lifecycle management
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Estonia
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• Importers & EU MA holders
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Estonia & EU
• Estonian Medicinal Products Act
• EU Directive 2001/83/EC
• EMA / CMDh Guidelines
• EudraLex Volume 4 – EU GMP
• ICH Q-Series & M-Series Guidelines
• EU CTD / eCTD Standards
• European Pharmacopoeia (Ph. Eur.)
Your Trusted Partner for DMF / ASMF Excellence in Estonia
Whether you are preparing a new EU ASMF, updating an existing dossier, supporting a SAM Estonia submission, or responding to EMA regulatory questions, DMF Direct delivers high-quality, compliant, and approval-focused DMF/ASMF solutions for the Estonian and European pharmaceutical markets.
✅ EU Regulatory-aligned
✅ Highly Confidential
✅ Technically Robust
✅ Approval-driven