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DossierTrans

Czech Republic Dossier & Technical Document Translation Services

Accurate. EU-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Czech Republic–specific and EU-aligned dossiers and technical documents, fully compliant with Czech regulatory authorities and European Union legislation.

We support Czech pharmaceutical manufacturers, MAHs, importers, distributors, CROs, regulatory consultants, and global companies targeting the Czech and wider EU market with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, approvals, inspections, and lifecycle compliance in the Czech Republic.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Czech and EU market, focused exclusively on scientific, pharmaceutical, biotechnology, medical device, food, and technical documentation.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and native-language technical reviewers—not general translators.

We ensure that translated dossiers consistently maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with SÚKL / EMA / EU regulatory expectations

Czech Republic Regulatory Alignment

Our services are fully aligned with the requirements of:

• State Institute for Drug Control (SÚKL) – Czech Republic
• European Medicines Agency (EMA)
• Heads of Medicines Agencies (HMA)
• European Commission – DG SANTE
• EU Clinical Trials Regulation (CTR 536/2014)
• CTIS / EudraCT systems
• Czech State Institute for Drug Control – Medical Devices Division
• EU Customs & Market Surveillance Authorities

Our Core Services – Czech Republic

📘 Dossier & Technical Document Translation

• Czech Republic– and EU-specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for National, MRP, DCP & Centralised procedures
• SmPC, PIL, labeling & artwork text (EU-compliant)
• Czech-language patient leaflets & labeling (mandatory)
• Clinical trial documentation (protocols, IBs, ICFs)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS & technical files
• Import, manufacturing authorization & GDP/GMP documentation

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents
• Cross-verification with source dossiers
• Identification of terminology errors, inconsistencies & EU compliance gaps
• Alignment with EMA guidelines, EU GMP/GDP, ICH & Ph. Eur. references

🛡️ Post-Submission Regulatory Query Handling – Czech Republic

• SÚKL / EMA questions & deficiency letters related to translated content
• Scientific clarification and EU-style regulatory re-wording support
• Revised translations responding to authority observations
• Coordination with local MAHs, Czech agents, EU consultants & CROs

Languages We Support (Czech Republic-Focused)

We provide professional, native-level regulatory translations relevant to Czech and EU submissions:

🌍 EU & International Languages

• English
• German
• French
• Spanish
• Italian
• Portuguese
• Russian

🇨🇿 Mandatory & Regional Language Support

• Czech – mandatory for labeling & PILs

Foreign Language ↔ Czech | Foreign Language ↔ English

All translations are reviewed by native Czech scientific and regulatory experts experienced with EU procedures.

Industries We Serve – Czech Republic

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biologics & Biosimilars
• Medical Devices & IVDs
• Clinical Trials & CROs
• OTC & Consumer Health Products
• Food Supplements & Nutraceuticals
• Chemicals & Specialty Materials

Why Choose DossierTrans for the Czech Republic?

✅ EU & Czech Republic–focused regulatory translation (not generic translation)
✅ Expertise in SÚKL, EMA, MRP/DCP & Centralised procedures
✅ Native Czech scientific & regulatory reviewers
✅ Consistent terminology aligned with EU legislation & Ph. Eur.
✅ Authority-ready multilingual documentation
✅ End-to-end support including post-approval queries & variations
✅ Strict confidentiality & data security

Global & Czech Republic Regulatory Expertise

Our Czech Republic services support:

• National and EU marketing authorizations
• Clinical trial submissions via CTIS
• Import & manufacturing authorization dossiers
• Export-support translations for EU & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence—especially in Czech PILs or labeling—can delay or block a national or EU approval.

That’s why we deliver precision-driven, regulator-acceptable translations, aligned with Czech and EU compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in the Czech Republic