DossierTrans

Romania Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Romania-specific dossiers and technical documents, fully aligned with Romanian and European Union regulatory requirements.

We support manufacturers, marketing authorization holders, importers, exporters, and regulatory consultants targeting Romania and the EU with precise, technically accurate, and authority-acceptable translations, ensuring smooth registrations, assessments, inspections, and approvals in Romania.

Who We Are

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

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

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Romanian National Agency for Medicines and Medical Devices (ANMDMR) and EU expectations

Romania Regulatory Alignment

Our services are aligned with the requirements of:

• National Agency for Medicines and Medical Devices of Romania (ANMDMR)
• Ministry of Health, Romania
• European Medicines Agency (EMA)
• European Commission – DG SANTE
• EU CTD / eCTD submission framework
• Romanian Customs & EU import–export authorities

Our Core Services – Romania

📘 Dossier & Technical Document Translation

• Romania-specific EU-CTD / national dossier formats
• Module 1–5 translations for ANMDMR & EMA submissions
• SmPC, PIL, labeling, packaging & artwork text (Romanian-compliant)
• Stability, validation, bioequivalence & clinical study reports
• SOPs, specifications, COAs, SDS & technical files
• Marketing authorization, variation, renewal & GMP documentation

🔍 Review of Translated Dossiers

• Scientific and regulatory review of translated documents
• Cross-verification against source (English) dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with EU Guidelines, EMA QRD templates, Ph. Eur., IP / BP / USP

🛡️ Post-Submission Regulatory Query Handling – Romania

• ANMDMR / EMA deficiency letters and questions related to translated content
• Scientific clarification and EU-compliant regulatory re-wording
• Revised translations as per assessment reports and authority comments
• Coordination with local MA holders, consultants, and EU agents

Languages We Support (Romania-Focused)

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

🌍 International & EU Languages

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

🇷🇴 Romania Regulatory Language

• Romanian (mandatory for national labeling & PILs)

English ↔ Romanian | EU Language ↔ Romanian

All translations are reviewed by scientific and regulatory experts familiar with Romanian and EU pharmaceutical legislation.

Industries We Serve – Romania

• Pharmaceuticals & APIs
• Medical Devices & IVDs
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicinal Products
• Food Supplements & Nutraceuticals
• Chemicals & Biocides
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Romania?

✅ Romania- and EU-regulatory-focused translation (not generic translation)
✅ Expertise in ANMDMR, EMA & EU-CTD documentation
✅ Native Romanian scientific reviewers
✅ Terminology consistency across EU submissions
✅ Authority-ready, inspection-acceptable documentation
✅ Lifecycle support: variations, renewals & post-approval changes
✅ Strict confidentiality & data security

Global & Romania Regulatory Expertise

Our Romania services support:

• National & EU marketing authorization dossiers
• MRP / DCP / Centralised Procedure submissions
• Import & export regulatory documentation
• Post-approval variations, renewals & compliance updates

Our Commitment

At DossierTrans, we understand that even a single mistranslated statement can delay or jeopardize a Romanian or EU approval.

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

DossierTrans – Translating Science into Regulatory Approval in Romania

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