DossierTrans

France 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 France-specific and EU-aligned dossiers and technical documents, fully compliant with French regulatory authorities and European Union legislation.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the French 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 ANSM / EMA / EU regulatory expectations

France Regulatory Alignment

Our services are fully aligned with the requirements of:

• National Agency for the Safety of Medicines and Health Products (ANSM) – France
• European Medicines Agency (EMA)
• Heads of Medicines Agencies (HMA)
• European Commission – DG SANTE
• EU Clinical Trials Regulation (CTR 536/2014)
• CTIS / EudraCT systems
• French Public Health Code (Code de la santé publique)
• EU Customs & Market Surveillance Authorities

Our Core Services – France

📘 Dossier & Technical Document Translation

• France- 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)
• French-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 ANSM guidance, EMA guidelines, EU GMP/GDP, ICH & Ph. Eur. references

🛡️ Post-Submission Regulatory Query Handling – France

• ANSM / 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, French agents, EU consultants & CROs

Languages We Support (France-Focused)

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

🌍 EU & International Languages

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

🇫🇷 Mandatory & Regional Language Support

• French – mandatory for labeling, PILs & national submissions

Foreign Language ↔ French | Foreign Language ↔ English

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

Industries We Serve – France

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
• Cosmetics & Dermocosmetics
• Chemicals & Specialty Materials

Why Choose DossierTrans for France?

✅ EU & France-focused regulatory translation (not generic translation)
✅ Expertise in ANSM, EMA, MRP/DCP & Centralised procedures
✅ Native French 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 & France Regulatory Expertise

Our France 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 French PILs or labeling—can delay or block a national or EU approval.

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

DossierTrans – Translating Science into Regulatory Approval in France