DossierTrans

Moldova 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 Moldova-specific dossiers and technical documents, fully aligned with Republic of Moldova regulatory requirements and EU-harmonized legislation.

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

Who We Are

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

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

We ensure that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Medicines and Medical Devices Agency (AMDM) and Ministry of Health expectations

Moldova Regulatory Alignment

Our services are aligned with the requirements of:

• Medicines and Medical Devices Agency (AMDM), Republic of Moldova
• Ministry of Health, Republic of Moldova
• EU-harmonized pharmaceutical legislation (as adopted by Moldova)
• State Pharmacopoeia and EU Pharmacopoeia references
• Moldovan Customs & Import–Export Authorities

Our Core Services – Moldova

📘 Dossier & Technical Document Translation

• Moldova-specific national and EU-harmonized dossier formats
• Module 1–5 translations for AMDM submissions
• SmPC, PIL, labeling, packaging & artwork text (Romanian-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 EU Guidelines, Ph. Eur., IP / BP / USP and AMDM guidance

🛡️ Post-Submission Regulatory Query Handling – Moldova

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

Languages We Support (Moldova-Focused)

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

🌍 International & Regional Languages

• English
• Russian
• German
• French

🇲🇩 Moldova Regulatory Language

• Romanian (Moldovan) – mandatory for national submissions
• Russian – accepted in specific regulatory and technical contexts

English ↔ Romanian | English ↔ Russian | Russian ↔ Romanian

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

Industries We Serve – Moldova

• 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 Moldova?

✅ Moldova-regulatory-focused translation (not generic translation)
✅ Expertise in AMDM & Ministry of Health documentation
✅ Native Romanian & Russian scientific reviewers
✅ Terminology consistency across submissions
✅ Authority-ready, expert-review-acceptable documentation
✅ Post-approval lifecycle support
✅ Strict confidentiality & data security

Global & Moldova Regulatory Expertise

Our Moldova services support:

• National marketing authorization dossiers
• EU-harmonized 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 Moldova.

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

DossierTrans – Translating Science into Regulatory Approval in Moldova

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