Drug Master File (DMF) Preparation, Review & Regulatory Support Services – Turkey
TİTCK (Turkey MOH)–Compliant DMF Documentation & Regulatory Support
By DMF Direct – A Scientific Arm of Zoesoe Exports Pvt Ltd
DMF Direct provides comprehensive Drug Master File (DMF) preparation, review, submission, and lifecycle management services specifically tailored for the Turkish pharmaceutical regulatory framework.
Our DMF services are designed to meet the requirements of the Turkish Medicines and Medical Devices Agency (TİTCK), Ministry of Health, Turkey and comply with:
Pharmaceutical and Medical Preparations Law, Turkey
TİTCK Drug Registration Regulations
EU GMP Guidelines adopted by Turkey
ICH Guidelines
CTD & eCTD-based submissions used for:
• API registration
• Finished pharmaceutical product (FPP) registration
• Import license & marketing authorization (MA) 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 Turkey.
Our Core DMF Services – Turkey
🧪 DMF Preparation – Open & Closed Parts (Turkey-Compliant)
We prepare complete, structured, and TİTCK-aligned DMF dossiers following the CTD / eCTD format mandatory for Turkey submissions.
Applicant’s Part (Open Part)
Prepared for submission to TİTCK / Local MA Holders / Importers, including:
• Quality Overall Summary (QOS) aligned with ICH Q2–Q6
• Non-confidential manufacturing and quality information
• Cross-reference-ready documentation for:
– API Registration
– Finished Product Registration
– Import License & Marketing Authorization
• CTD/eCTD-structured documentation suitable for Turkey and EU-linked exports
Restricted Part (Closed / Confidential Part)
Secure preparation and handling of proprietary technical information, including:
• Detailed manufacturing process and process flow diagrams
• Critical process parameters and in-process controls
• Raw materials, intermediates, and finished product specifications
• Analytical methods and method validation (ICH Q2)
• Control strategy and pharmaceutical quality system (PQS)
• Stability data as per ICH climatic Zone II & IVb (as applicable for Turkey)
✅ Confidential data is disclosed strictly to TİTCK regulators and never to local applicants or distributors.
DMF Types Covered – Turkey
We support 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 – Turkey
Already have a DMF for Turkey?
We conduct Turkey-specific DMF review and risk assessment based on:
• TİTCK technical expectations & inspection practices
• EU GMP compliance gaps
• CTD/eCTD structure and content deficiencies
• Manufacturing, validation, and stability inconsistencies
• Likely TİTCK deficiency triggers
✔️ You receive a clear, actionable gap assessment report before submission or inspection.
🧪 TİTCK Submission & Turkey Regulatory Support
We provide hands-on support for DMF usage and filing in Turkey, including:
• TİTCK submissions and clarifications
• API registration support
• Finished product registration support
• Import license & marketing authorization dossiers
• Export-linked DMF alignment
Our team ensures:
• Correct CTD/eCTD formatting
• Accurate cross-referencing
• Consistency across DMF, TİTCK dossiers, and manufacturing records
🧪 DMF Lifecycle Management & Maintenance – Turkey
We manage your DMF throughout its complete regulatory lifecycle, including:
• Initial DMF compilation
• Annual updates and post-approval variations
• Manufacturing site changes
• Process optimization or scale-up documentation
• Stability updates (real-time & accelerated)
• Specification and analytical method revisions
• TİTCK-driven amendments and updates
🧪 Post-Submission Deficiency & Query Handling – TİTCK
Complete post-submission regulatory support for Turkey, including:
• TİTCK deficiency letters and technical queries
• Scientific justification and response drafting
• Revised Open & Closed Part submissions
• Alignment with MA holder responses
• Coordination between manufacturer, MA holder, and TİTCK authority
🎯 Goal: Faster approvals, fewer queries, and regulator-ready documentation.
🧪 Why Choose DMF Direct for Turkey?
🧪 In-depth knowledge of TİTCK & Turkish regulatory pathways
🧪 Expertise in EU GMP & ICH-aligned DMF documentation
🧪 Secure handling of confidential manufacturing information
🧪 Strong TİTCK deficiency response experience
🧪 Seamless coordination with Turkish MA holders & importers
🧪 Backed by Zoesoe Exports Pvt Ltd’s regulatory strength
Industries We Support – Turkey
• API manufacturers
• Finished formulation manufacturers (FDF)
• Excipient manufacturers
• Packaging material suppliers
• MA holders, importers & distributors
• Contract manufacturing organizations (CMOs)
Regulatory Standards Followed – Turkey
• Turkish Pharmaceutical Law & TİTCK Regulations
• EU GMP (as adopted by Turkey)
• ICH Q-Series & M-Series Guidelines
• CTD / eCTD-ready documentation
• WHO GMP & Technical Reports
Your Trusted Partner for DMF Excellence in Turkey
Whether you are preparing a new DMF, updating an existing dossier, supporting a TİTCK submission, or responding to regulatory queries, DMF Direct delivers high-quality, compliant, and approval-focused DMF solutions for the Turkish market.
✅ Regulatory-aligned
✅ Confidential
✅ Efficient
✅ Approval-driven