DossierTrans

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

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Finnish and EU market, focused exclusively on scientific, pharmaceutical, medical device, biotechnology, 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 Fimea / EMA / EU regulatory expectations

Finland Regulatory Alignment

Our services are fully aligned with the requirements of:

• Finnish Medicines Agency (Fimea) – Finland
• European Medicines Agency (EMA)
• Heads of Medicines Agencies (HMA)
• European Commission – DG SANTE
• EU Clinical Trials Regulation (CTR 536/2014)
• CTIS / EudraCT systems
• Finnish Institute for Health and Welfare (THL) – where applicable
• EU Customs & Market Surveillance Authorities

Our Core Services – Finland

📘 Dossier & Technical Document Translation

• Finland- 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)
• Finnish- and Swedish-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 – Finland

• Fimea / 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, Finnish agents, EU consultants & CROs

Languages We Support (Finland-Focused)

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

🌍 EU & International Languages

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

🇫🇮 Mandatory & Regional Language Support

• Finnish – mandatory
• Swedish – mandatory

Foreign Language ↔ Finnish | Foreign Language ↔ Swedish | Foreign Language ↔ English

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

Industries We Serve – Finland

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biologics & Biosimilars
• Biotechnology & Advanced Therapies (ATMPs)
• Medical Devices & IVDs
• Clinical Trials & CROs
• OTC & Consumer Health Products
• Food Supplements & Nutraceuticals
• Chemicals & Specialty Materials

Why Choose DossierTrans for Finland?

✅ EU & Finland-focused regulatory translation (not generic translation)
✅ Expertise in Fimea, EMA, MRP/DCP & Centralised procedures
✅ Native Finnish & Swedish scientific and 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 & Finland Regulatory Expertise

Our Finland 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 Finnish or Swedish PILs or labeling—can delay or block a national or EU approval.

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

DossierTrans – Translating Science into Regulatory Approval in Finland