DossierTrans – Turkey
Turkey Dossier & Technical Document Translation Services
Accurate. Regulatory-Compliant. Authority-Ready.
DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, technical review, and regulatory query support for Turkey-specific dossiers and technical documents, aligned with Turkish regulatory authorities and statutory requirements.
We support Turkish manufacturers, importers, exporters, marketing authorization holders, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in Turkey.
Who We Are
DossierTrans is a specialized regulatory translation service provider for the Turkish market, focused exclusively on scientific, pharmaceutical, and technical documentation.
All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers—not general translators.
We ensure every translated dossier preserves:
• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Turkey-specific TITCK / MoH expectations
Turkey Regulatory Alignment
Our services are aligned with the requirements of:
• Turkish Medicines and Medical Devices Agency (TİTCK)
• Ministry of Health (MoH), Republic of Türkiye
• Regulation on Licensing of Medicinal Products for Human Use
• EU-aligned CTD / eCTD requirements
• Turkish Pharmacopoeia / EU Pharmacopoeia (Ph. Eur.)
• Turkish Standards Institution (TSE)
• Turkish Customs Administration
• Other applicable import & export regulatory authorities in Turkey
Our Core Services – Turkey
📘 Dossier & Technical Document Translation
• Turkey-specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for TİTCK submissions
• Prescribing information, SmPC, labels, package leaflets & artwork text (Turkish-compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import license & export documentation
🔍 Review of Translated Dossiers
• Scientific and technical review of translated documents
• Cross-verification with source-language dossiers
• Identification of terminology errors, inconsistencies & regulatory gaps
• Alignment with TİTCK guidance, EU CTD requirements, and Ph. Eur. references
🛡️ Post-Submission Regulatory Query Handling – Turkey
• TİTCK / MoH queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, local agents, MAHs, and consultants
Languages We Support (Turkey-Focused)
🌍 International Languages
• English
• French
• German
• Spanish
• Italian
• Portuguese
• Russian
• Arabic
• Chinese (Simplified & Traditional)
• Japanese
• Korean
🇹🇷 Local & Regional Language Support
• Turkish
• English (Turkey regulatory format)
English ↔ Turkish | Foreign Language ↔ English / Turkish
All translations are reviewed by regulatory experts experienced with TİTCK and EU-aligned submission requirements.
Industries We Serve – Turkey
• Pharmaceuticals & APIs
• Medical Devices
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Herbal & Traditional Medicines
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals
Why Choose DossierTrans for Turkey?
✅ Turkey-regulatory-focused translation (not generic translation)
✅ Proven expertise in TİTCK & EU-aligned CTD/eCTD documentation
✅ Native-language scientific & regulatory reviewers
✅ Terminology consistency across Turkish submissions
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security
Global & Turkey Regulatory Expertise
Our Turkey services support:
• TİTCK product registration & variation dossiers
• Manufacturing & marketing authorization documentation
• Import license & customs documentation
• Export-support translations for EU, CIS, Middle East & ROW markets
• Post-approval variations, renewals & lifecycle management
Our Commitment
At DossierTrans, we understand that a single mistranslated sentence can delay or reject a TİTCK approval in Turkey.
That’s why we deliver precision-driven, regulator-acceptable translations, fully aligned with Turkish compliance expectations—every time.
DossierTrans – Translating Science into Regulatory Approval in Turkey
If you want next, I can:
✔ Prepare SEO-optimized Turkey landing page content
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✔ Convert this for EU countries, GCC, CIS, Africa, or LATAM