DossierTrans – Russia

Russia Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, technical review, and regulatory query support for Russia-specific dossiers and technical documents, aligned with Russian regulatory authorities and statutory requirements.

We support Russian manufacturers, importers, exporters, marketing authorization holders, EAEU applicants, distributors, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in the Russian Federation.

Who We Are

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

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

We ensure every translated dossier preserves:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Russia-specific MoH / EAEU expert expectations

Russia Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Health of the Russian Federation (Minzdrav)
• Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP / FGBU “NCESMP”)
• Federal Service for Surveillance in Healthcare (Roszdravnadzor)
• Eurasian Economic Union (EAEU) pharmaceutical regulations
• EAEU CTD / eCTD requirements
• State Pharmacopoeia of the Russian Federation
• Federal Customs Service of Russia (EAEU Customs Union)
• Other applicable import & export regulatory authorities in Russia

Our Core Services – Russia

📘 Dossier & Technical Document Translation

• Russia-specific national and EAEU CTD dossier formats
• Module 1–5 translations for Minzdrav / SCEEMP submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (Russian-compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, EAEU alignment, import permit & export documentation

🔍 Review of Translated Dossiers

• Scientific and technical review of translated documents
• Cross-verification with source-language dossiers
• Identification of terminology errors, inconsistencies & EAEU/Russia compliance gaps
• Alignment with Minzdrav, SCEEMP, and EAEU requirements, including accepted pharmacopoeias (State Pharmacopoeia RF, Ph. Eur., USP, BP)

🛡️ Post-Submission Regulatory Query Handling – Russia

• Minzdrav / SCEEMP / Roszdravnadzor queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations as per authority observations
• Coordination with EAEU applicants, local agents, distributors, and consultants

Languages We Support (Russia-Focused)

🌍 International Languages

• English
• German
• French
• Spanish
• Italian
• Portuguese
• Arabic
• Chinese (Simplified & Traditional)
• Japanese
• Korean

🇷🇺 Local & Regional Language Support

• Russian (mandatory regulatory language)
• English (for reference and import/export dossiers)

English ↔ Russian | Foreign Language ↔ English / Russian

All translations are reviewed by regulatory experts experienced with Russian Minzdrav, SCEEMP, and EAEU requirements.

Industries We Serve – Russia

• Pharmaceuticals & APIs
• Medical Devices & IVDs
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food Supplements & Nutraceuticals
• Herbal & Traditional Medicines
• Chemicals & Industrial Substances

Why Choose DossierTrans for Russia?

✅ Russia & EAEU-regulatory-focused translation (not generic translation)
✅ Proven expertise in Minzdrav, SCEEMP & EAEU documentation
✅ Native Russian scientific and regulatory reviewers
✅ Terminology consistency across Russian & EAEU submissions
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security

Global & Russia Regulatory Expertise

Our Russia services support:

• National & EAEU-aligned product registration dossiers
• Manufacturing & marketing authorization documentation
• Import permit & customs documentation
• Export-support translations for EAEU, CIS & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a Minzdrav or EAEU approval in Russia.

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

DossierTrans – Translating Science into Regulatory Approval in Russia

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