Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Hungary
OGYÉI & EMA–Compliant DMF / ASMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides end-to-end Drug Master File (DMF) / Active Substance Master File (ASMF) preparation, review, submission, and lifecycle management services specifically tailored for Hungary and the European Union regulatory framework.
Our DMF/ASMF services are designed to meet the expectations of:
OGYÉI – National Institute of Pharmacy and Nutrition (Hungary)
European Medicines Agency (EMA)
EU Competent Authorities (Decentralized & Mutual Recognition Procedures)
And comply with:
EU Pharmaceutical Legislation
EudraLex Volume 2 & 4
EU GMP (Part I, II & QP Requirements)
ICH Guidelines
CTD / eCTD dossier formats used for:
• API technical registration in Hungary & EU
• Finished formulation (FPP) marketing authorization
• Import & batch release (QP) support
• Decentralized (DCP) & Mutual Recognition (MRP) Procedures
• Export-oriented EU regulatory submissions
We specialize in the preparation and maintenance of both:
Open Part (Applicant’s Part)
Restricted Part (Closed / Confidential Part)
Ensuring full regulatory compliance, strict confidentiality, and smooth approval processing with OGYÉI & EMA.
Our Core DMF / ASMF Services – Hungary
🧪 DMF / ASMF Preparation – Open & Closed Parts (EU & Hungary–Compliant)
We prepare complete, structured, and EU-aligned ASMF dossiers following CTD/eCTD formats accepted across Hungary and all EU member states.
Applicant’s Part (Open Part)
Prepared for submission to OGYÉI / EMA / EU Marketing Authorization Holders (MAHs), including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– Centralized, DCP & MRP submissions
– National Hungarian Marketing Authorization
– EU Import & Batch Release (QP Declarations)
• CTD-structured documentation suitable for all EU regulatory pathways
Restricted Part (Closed / Confidential Part)
Secure preparation and controlled handling of proprietary technical information, including:
• Detailed manufacturing process & process validation
• Critical process parameters & in-process controls
• Raw materials, intermediates & finished product specifications
• Analytical methods & validation (ICH Q2 + European Pharmacopoeia)
• Control strategy & Pharmaceutical Quality System (PQS)
• Stability data as per EU climatic zone (Zone I & II where applicable)
✅ Confidential data is disclosed only to OGYÉI / EMA assessors — not to MAHs or commercial partners.
DMF / ASMF Types Covered – Hungary
We support DMF / ASMF documentation for:
• API / Drug Substance (Active Substance Master Files)
• Packaging Materials
• Excipients
• Reference / Miscellaneous Technical Information
🧪 DMF / ASMF Review & Gap Assessment – Hungary
Already have a DMF / ASMF for Hungary or EU?
We conduct Hungary- and EU-specific DMF / ASMF review and regulatory risk assessment based on:
• OGYÉI & EMA quality assessment expectations
• EU GMP Part II compliance gaps
• CTD / eCTD structure & content deficiencies
• Manufacturing, validation & stability inconsistencies
• Likely EU deficiency & assessment query triggers
✔️ You receive a clear, actionable gap assessment report before OGYÉI / EMA submission or inspection.
🧪 OGYÉI / EMA Submission & Hungary Regulatory Support
We provide hands-on support for DMF / ASMF filing and regulatory usage in Hungary & across the EU, including:
• OGYÉI national submissions
• EMA centralized & DCP/MRP submissions
• API registration & ASMF technical linkage
• Import testing & QP release documentation
• EU-wide MAH support & regulatory coordination
Our team ensures:
• Correct CTD / eCTD formatting
• Accurate cross-referencing
• Full consistency across DMF/ASMF, marketing authorization dossiers, and manufacturing records
🧪 DMF / ASMF Lifecycle Management & Maintenance – Hungary
We manage your DMF / ASMF through its complete regulatory lifecycle, including:
• Initial ASMF compilation
• Annual updates & variations
• Manufacturing site changes
• Process optimization & scale-up documentation
• Stability updates (real-time & accelerated)
• Specification & analytical method revisions
• OGYÉI / EMA-driven post-approval variations
🧪 Post-Submission Deficiency & Query Handling – Hungary
Complete post-submission regulatory support, including:
• OGYÉI & EMA deficiency letters
• Scientific justification & response drafting
• Revised Open & Closed Part submissions
• Alignment with EU MAHs & QPs
• Coordination between manufacturer, MAH & regulators
🎯 Goal: Faster approvals, fewer queries, and EU-ready DMF / ASMF documentation.
🧪 Why Choose DMF Direct for Hungary?
🧪 Deep expertise in OGYÉI, EMA & EU DCP/MRP regulatory pathways
🧪 Strong experience with EU GMP Part II & ICH-aligned ASMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Proven EU deficiency & technical query response success
🧪 Seamless coordination with Hungarian & EU MAHs, QPs & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s global regulatory strength
Industries We Support – Hungary
• API manufacturers
• Finished formulation (FPP) manufacturers
• Excipient manufacturers
• Packaging material suppliers
• EU importers & MAHs
• Contract Manufacturing Organizations (CMOs)
• Export-focused pharma companies
Regulatory Standards Followed – Hungary
• EU Pharmaceutical Legislation
• OGYÉI & EMA Guidelines
• EU GMP (EudraLex Vol. 4)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• European Pharmacopoeia
• WHO-GMP (where applicable)
Your Trusted Partner for DMF / ASMF Excellence in Hungary
Whether you are preparing a new ASMF for Hungary, updating an existing EU technical file, supporting a DCP/MRP submission, appointing an EU MAH, or responding to OGYÉI / EMA queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF / ASMF solutions for the Hungarian and European markets.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven
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