DossierTrans – Kazakhstan

Kazakhstan 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 Kazakhstan-specific dossiers and technical documents, aligned with Kazakhstani regulatory authorities and statutory requirements.

We support Kazakhstani 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 Kazakhstan.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Kazakhstan 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 Kazakhstan-specific MoH / NCELS expectations

Kazakhstan Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Health of the Republic of Kazakhstan
• National Center for Expertise of Medicines and Medical Devices (NCEMMD / NCELS)
• Code of the Republic of Kazakhstan “On People’s Health and the Healthcare System”
• Eurasian Economic Union (EAEU) pharmaceutical regulations
• EAEU CTD / eCTD requirements for medicines & medical devices
• Kazakhstan Customs Authorities (EAEU Customs Union)
• Other applicable import & export regulatory authorities in Kazakhstan

Our Core Services – Kazakhstan

📘 Dossier & Technical Document Translation

• Kazakhstan-specific national and EAEU CTD dossier formats
• Module 1–5 translations for NCELS submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (Kazakh / 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 compliance gaps
• Alignment with NCELS requirements, MoH guidance, and accepted pharmacopoeias (Ph. Eur., USP, BP, EP)

🛡️ Post-Submission Regulatory Query Handling – Kazakhstan

• NCELS / Ministry of Health 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 (Kazakhstan-Focused)

🌍 International Languages

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

🇰🇿 Local & Regional Language Support

• Russian (primary regulatory language)
• Kazakh (state language)
• English (for reference and import/export dossiers)

English ↔ Russian | English ↔ Kazakh | Foreign Language ↔ English / Russian / Kazakh

All translations are reviewed by regulatory experts experienced with Kazakhstan MoH, NCELS, and EAEU requirements.

Industries We Serve – Kazakhstan

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

Why Choose DossierTrans for Kazakhstan?

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

Global & Kazakhstan Regulatory Expertise

Our Kazakhstan 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 an NCELS or EAEU approval in Kazakhstan.

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

DossierTrans – Translating Science into Regulatory Approval in Kazakhstan

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