DossierTrans

Spain 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 Spain-specific dossiers and technical documents, fully aligned with Spanish and European Union regulatory requirements.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Spanish 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 Spanish Agency of Medicines and Medical Devices (AEMPS) and EU expectations

Spain Regulatory Alignment

Our services are aligned with the requirements of:

• Spanish Agency of Medicines and Medical Devices (AEMPS)
• Ministry of Health, Government of Spain
• European Medicines Agency (EMA)
• European Commission – DG SANTE
• EU CTD / eCTD submission framework
• Spanish Customs & EU import–export authorities

Our Core Services – Spain

📘 Dossier & Technical Document Translation

• Spain-specific EU-CTD / national dossier formats
• Module 1–5 translations for AEMPS & EMA submissions
• SmPC, PIL, labeling, packaging & artwork text (Spanish-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 – Spain

• AEMPS / 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 (Spain-Focused)

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

🌍 International & EU Languages

• English
• German
• French
• Italian
• Portuguese

🇪🇸 Spain Regulatory Language

• Spanish (Castilian) – mandatory for national labeling & PILs
• Regional languages (Catalan, Galician, Basque) – where required

English ↔ Spanish | EU Language ↔ Spanish

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

Industries We Serve – Spain

• 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 Spain?

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

Global & Spain Regulatory Expertise

Our Spain 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 Spanish or EU approval.

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

DossierTrans – Translating Science into Regulatory Approval in Spain

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