DossierTrans

Armenia Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, review, and regulatory query support for Armenia-specific dossiers and technical documents, fully aligned with Republic of Armenia and EAEU regulatory requirements.

We support manufacturers, marketing authorization holders, importers, exporters, and regulatory consultants targeting Armenia with precise, technically accurate, and authority-acceptable translations, ensuring smooth registrations, expert evaluations, inspections, and approvals in Armenia.

Who We Are

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

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

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Ministry of Health (MoH) Armenia / Center of Drug and Medical Technology Expertise (CDMTE) expectations

Armenia Regulatory Alignment

Our services are aligned with the requirements of:

Ministry of Health, Republic of Armenia
Center of Drug and Medical Technology Expertise (CDMTE)
EAEU pharmaceutical regulatory framework
State Pharmacopoeia and EAEU Pharmacopoeial references
Armenian Customs & Import–Export Authorities

Our Core Services – Armenia

📘 Dossier & Technical Document Translation

• Armenia-specific national and EAEU-aligned dossier formats
Module 1–5 translations for MoH / CDMTE submissions
SmPC, PIL, labeling, packaging & artwork text (Armenian/Russian compliant)
Stability, validation, bioequivalence & clinical study reports
SOPs, specifications, COAs, SDS & technical files
Marketing authorization, variation, renewal & GMP documentation

🔍 Review of Translated Dossiers

• Scientific and regulatory review of translated documents
• Cross-verification against source (English) dossiers
• Identification of terminology errors, inconsistencies & compliance gaps
• Alignment with EAEU Guidelines, IP / BP / USP, and Armenian regulatory guidance

🛡️ Post-Submission Regulatory Query Handling – Armenia

MoH / CDMTE deficiency letters and expert queries related to translated content
• Scientific clarification and Armenia-compliant regulatory re-wording
• Revised translations based on expert assessment reports
• Coordination with local MA holders, consultants, and importers

Languages We Support (Armenia-Focused)

We provide professional, native-level regulatory translations relevant to Armenia registrations:

🌍 International & Regional Languages

• English
• Russian
• German
• French

🇦🇲 Armenia Regulatory Language

Armenian – mandatory for national submissions
Russian – accepted within EAEU-aligned documentation

English ↔ Armenian | English ↔ Russian | Russian ↔ Armenian

All translations are reviewed by scientific and regulatory experts familiar with Armenian and EAEU pharmaceutical legislation.

Industries We Serve – Armenia

• Pharmaceuticals & APIs
• Medical Devices & IVDs
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicinal Products
• Food Supplements & Nutraceuticals
• Chemicals & Biocides
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Armenia?

✅ Armenia-regulatory-focused translation (not generic translation)
✅ Expertise in MoH Armenia, CDMTE & EAEU documentation
✅ Native Armenian & Russian scientific reviewers
✅ Terminology consistency across submissions
Authority-ready, expert-review-acceptable documentation
✅ Post-approval lifecycle support
✅ Strict confidentiality & data security

Global & Armenia Regulatory Expertise

Our Armenia services support:

National and EAEU marketing authorization dossiers
EAEU-aligned registration pathways
Import & export regulatory documentation
Post-approval variations, renewals & compliance updates

Our Commitment

At DossierTrans, we understand that even a single mistranslated statement can delay or block an approval in Armenia.

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

DossierTrans – Translating Science into Regulatory Approval in Armenia

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