DossierTrans

🇺🇦 Ukraine 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 Ukraine-specific dossiers and technical documents, aligned with Ukrainian regulatory authorities and statutory requirements.

We support Ukrainian manufacturers, exporters, importers, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and approvals in Ukraine.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Ukrainian 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 that translated dossiers maintain:

• Scientific accuracy

• Regulatory intent

• Terminology consistency

• Compliance with Ukraine-specific State Expert Center (SEC) of the Ministry of Health expectations, often aligning with EU/ICH guidelines.

Ukrainian Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Health of Ukraine (MoH)

• State Expert Center (SEC) (for drug registration)

• State Service of Ukraine on Medicines and Drugs Control (SMDC)

• State Service of Ukraine on Food Safety and Consumer Protection

• Import & Export regulatory agencies in Ukraine

Our Core Services – Ukraine

📘 Dossier & Technical Document Translation

• Ukraine-specific formats, including CTD/eCTD submissions.

• Translation of Modules 1-5 for SEC submissions.

• SmPC, PIL, labels, leaflets & artwork text (Ukraine-compliant).

• Stability, validation & study reports.

• SOPs, specifications, COAs, SDS & technical files.

• Import registration and licensing documentation.

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents.

• Cross-verification with source (English) dossiers.

• Identification of terminology errors, inconsistencies & compliance gaps.

• Alignment with State Pharmacopoeia of Ukraine (SPhU) and MoH regulatory references, often leveraging EU standards.

🛡️ Post-Submission Regulatory Query Handling – Ukraine

• SEC / MoH / SMDC queries related to translated content.

• Scientific clarification and regulatory re-wording support.

• Revised translations as per authority observations.

• Coordination with applicants, consultants, and local agents.

Languages We Support (Ukraine-Focused)

We provide professional, native-level regulatory translations relevant to Ukrainian submissions and imports:

🌍 International Languages (for Ukraine Import & Export)🇺🇦 Ukrainian & Regional Language Support (as applicable)Russian ↔ English (Often used in documentation)Ukrainian ↔ EnglishFrenchRussian ↔ UkrainianGermanEnglish (Ukrainian regulatory format)SpanishOther regional languages – on requestItalianPortugueseArabicChinese (Simplified & Traditional)JapaneseKorean

English ↔ Local Language | Local Language ↔ English | Russian ↔ Local Language

All translations are reviewed by scientific and regulatory experts familiar with Ukrainian regulations.

Industries We Serve – Ukraine

We provide specialized translation and review services for:

• Pharmaceuticals & APIs

• Medical Devices (in line with Technical Regulations based on EU Directives)

• Cosmetics & Personal Care

• Food & Nutraceutical Ingredients

• Agrochemicals

• Industrial Chemicals

Why Choose DossierTrans for Ukraine?

✅ Ukraine-regulatory-focused translation (not generic translation).

✅ Expertise in SEC, MoH, and EU-aligned documentation.

✅ Native-language scientific reviewers.

✅ Terminology consistency across Ukrainian submissions.

✅ Authority-ready documentation.

✅ End-to-end support including post-approval queries.

✅ Strict confidentiality & data security.

Global & Ukrainian Regulatory Expertise

Our Ukraine services support:

• Import registration dossiers.

• Manufacturing & marketing authorization documents.

• Export-support translations for ROW markets.

• Post-approval variations & renewals.

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a Ukrainian regulatory approval. That’s why we deliver precision-driven, regulator-acceptable translations aligned with Ukrainian compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Ukraine.