DossierTrans
Norway Dossier & Technical Document Translation Services
Accurate. EEA-Compliant. Authority-Ready.
DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Norway-specific and EEA-aligned dossiers and technical documents, fully compliant with Norwegian regulatory authorities and European Economic Area (EEA) legislation.
We support Norwegian pharmaceutical manufacturers, MAHs, importers, distributors, CROs, regulatory consultants, and global companies targeting the Norwegian and EEA market with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, approvals, inspections, and lifecycle compliance in Norway.
Who We Are
DossierTrans is a specialized regulatory translation service provider for the Norwegian and EEA 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 NoMA / EMA / EEA regulatory expectations
Norway Regulatory Alignment
Our services are fully aligned with the requirements of:
• Norwegian Medicines Agency (NoMA)
• European Medicines Agency (EMA)
• Heads of Medicines Agencies (HMA)
• EEA Agreement – pharmaceutical acquis
• EU Clinical Trials Regulation (CTR 536/2014) – applied in EEA
• CTIS / EudraCT systems
• Norwegian Directorate of Health
• EEA Customs & Market Surveillance Authorities
Our Core Services – Norway
📘 Dossier & Technical Document Translation
• Norway- and EEA-specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for National, MRP, DCP & Centralised procedures
• SmPC, PIL, labeling & artwork text (EEA-compliant)
• Norwegian-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 & EEA compliance gaps
• Alignment with EMA guidelines, EEA GMP/GDP, ICH & Ph. Eur. references
🛡️ Post-Submission Regulatory Query Handling – Norway
• NoMA / EMA questions & deficiency letters related to translated content
• Scientific clarification and EEA-style regulatory re-wording support
• Revised translations responding to authority observations
• Coordination with local MAHs, Norwegian agents, EEA consultants & CROs
Languages We Support (Norway-Focused)
We provide professional, native-level regulatory translations relevant to Norwegian and EEA submissions:
🌍 EU / EEA & International Languages
• English
• German
• French
• Spanish
• Italian
• Portuguese
• Russian
🇳🇴 Mandatory & Regional Language Support
• Norwegian (Bokmål) – mandatory
• Norwegian (Nynorsk) – on request (region-dependent)
Foreign Language ↔ Norwegian | Foreign Language ↔ English
All translations are reviewed by native Norwegian scientific and regulatory experts experienced with EEA procedures.
Industries We Serve – Norway
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 Norway?
✅ EEA & Norway-focused regulatory translation (not generic translation)
✅ Expertise in NoMA, EMA, MRP/DCP & Centralised procedures
✅ Native Norwegian scientific & regulatory reviewers
✅ Consistent terminology aligned with EEA legislation & Ph. Eur.
✅ Authority-ready multilingual documentation
✅ End-to-end support including post-approval queries & variations
✅ Strict confidentiality & data security
Global & Norway Regulatory Expertise
Our Norway services support:
• National and EEA marketing authorizations
• Clinical trial submissions via CTIS
• Import & manufacturing authorization dossiers
• Export-support translations for EEA & ROW markets
• Post-approval variations, renewals & lifecycle management
Our Commitment
At DossierTrans, we understand that a single mistranslated sentence—especially in Norwegian PILs or labeling—can delay or block a national or EEA approval.
That’s why we deliver precision-driven, regulator-acceptable translations, aligned with Norwegian and EEA compliance expectations—every time.
DossierTrans – Translating Science into Regulatory Approval in Norway