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