DossierTrans – Ethiopia

Ethiopia 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 Ethiopia-specific dossiers and technical documents, aligned with Ethiopian regulatory authorities and statutory requirements.

We support Ethiopian manufacturers, importers, exporters, marketing authorization holders, NGOs, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in Ethiopia.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Ethiopian 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 Ethiopia-specific EFDA / MoH expectations

Ethiopia Regulatory Alignment

Our services are aligned with the requirements of:

• Ethiopian Food and Drug Authority (EFDA)
• Ministry of Health (MoH), Federal Democratic Republic of Ethiopia
• EFDA Medicines Registration & Import Regulations
• Public Health Institute (EPHI) – quality and control support
• Ethiopian Pharmacopoeia / EFDA-accepted international pharmacopoeias (USP, BP, EP)
• Ethiopian Customs Commission (ECC)
• Other applicable import & export regulatory authorities in Ethiopia

Our Core Services – Ethiopia

📘 Dossier & Technical Document Translation

• Ethiopia-specific CTD / non-CTD dossier formats
• Module 1–5 translations for EFDA submissions
• Prescribing information, labels, package inserts, leaflets & artwork text (English / Amharic compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, 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 & regulatory gaps
• Alignment with EFDA guidance, Ethiopian regulations, and pharmacopoeial references

🛡️ Post-Submission Regulatory Query Handling – Ethiopia

• EFDA / MoH queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, local agents, NGOs, and consultants

Languages We Support (Ethiopia-Focused)

🌍 International Languages

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

🇪🇹 Local & Regional Language Support

• Amharic
• English (Ethiopian regulatory format)

English ↔ Amharic | Foreign Language ↔ English / Amharic

All translations are reviewed by regulatory experts experienced with EFDA requirements.

Industries We Serve – Ethiopia

• Pharmaceuticals & APIs
• Medical Devices
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Herbal & Traditional Medicines
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Ethiopia?

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

Global & Ethiopia Regulatory Expertise

Our Ethiopia services support:

• EFDA product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Import permit & customs documentation
• Export-support translations for Horn of Africa, Africa & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject an EFDA approval in Ethiopia.

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

DossierTrans – Translating Science into Regulatory Approval in Ethiopia

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