DossierTrans

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

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Irish 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 HPRA / EMA / EU regulatory expectations

Ireland Regulatory Alignment

Our services are fully aligned with the requirements of:

• Health Products Regulatory Authority (HPRA) – Ireland
• European Medicines Agency (EMA)
• Heads of Medicines Agencies (HMA)
• European Commission – DG SANTE
• EU Clinical Trials Regulation (CTR 536/2014)
• CTIS / EudraCT systems
• Health Service Executive (HSE) – where applicable
• EU Customs & Market Surveillance Authorities

Our Core Services – Ireland

📘 Dossier & Technical Document Translation

• Ireland- 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)
• English-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 – Ireland

• HPRA / 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, Irish agents, EU consultants & CROs

Languages We Support (Ireland-Focused)

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

🌍 EU & International Languages

• English (primary regulatory language)
• German
• French
• Spanish
• Italian
• Portuguese
• Russian

🇮🇪 Additional Language Support (as required)

• Irish (Gaeilge) – on request for public-health or patient-facing materials

Foreign Language ↔ English

All translations are reviewed by scientific and regulatory experts familiar with HPRA and EU procedures.

Industries We Serve – Ireland

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 Ireland?

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

Global & Ireland Regulatory Expertise

Our Ireland 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 SmPCs, PILs, or regulatory correspondence—can delay or jeopardize an HPRA or EU approval.

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

DossierTrans – Translating Science into Regulatory Approval in Ireland