DossierTrans-Africa
Global Dossier & Technical Document Translation Services for African Regulatory Markets
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 dossiers and technical documents for African regulatory markets.
We support pharmaceutical, nutraceutical, herbal, cosmetic, veterinary, and chemical manufacturers exporting to Africa with scientifically accurate and regulatory-compliant translations required for submissions to African Medicines Regulatory Authorities (MRAs).
Our services help ensure smooth dossier submissions, faster regulatory approvals, and minimal authority queries.
Who We Are
DossierTrans is a specialized regulatory translation service provider dedicated to pharmaceutical and technical documentation used in regulatory submissions across Africa.
Unlike general translation agencies, our work is performed by:
• Regulatory affairs specialists
• Pharmaceutical scientists
• Technical document writers
• Native-language scientific reviewers
This ensures that translated dossiers maintain:
• Scientific accuracy
• Regulatory intent and clarity
• Terminology consistency across documents
• Compliance with African MOH regulatory expectations
Our Core Services
📘 Dossier & Technical Document Translation
We provide regulatory dossier translation services required for product registrations in African countries.
Our services include:
• CTD, eCTD, ACTD & country-specific dossier formats
• Module 1–5 dossier translations
• SmPC, PIL, labels, pack inserts & artwork text
• Stability study reports and validation reports
• Clinical and non-clinical reports
• SOPs, technical files, specifications & COAs
• Safety Data Sheets (SDS)
🔍 Scientific Review of Translated Dossiers
Translation alone is not sufficient for regulatory submission. We perform scientific and regulatory review of translated documents.
Our review includes:
• Cross-verification with original English dossier
• Identification of terminology errors and inconsistencies
• Correction of scientific interpretation issues
• Alignment with regulatory authority expectations
🛡️ Post-Submission Regulatory Query Handling
African regulatory authorities may raise queries related to translated documents during dossier evaluation.
We provide full support for:
• MOH queries related to translated content
• Scientific clarification and revised wording
• Updated translations based on authority comments
• Coordination with applicants and local regulatory agents
African Languages We Support
Many African regulatory authorities require product information in official national languages.
We provide professional regulatory translations in:
🌍 Major African Regulatory Languages
• French
• Portuguese
• Arabic
• English
🌍 Regional Languages (Where Required)
• Swahili
• Amharic
🌍 European Languages Used in Africa
• French (West & Central Africa)
• Portuguese (Angola, Mozambique)
• Arabic (North Africa)
Translation Direction
English ↔ Local Language
Local Language ↔ English
All translations are scientifically reviewed before final delivery.
Industries We Serve
We support regulatory submissions and documentation for:
• Pharmaceutical Products & APIs
• Veterinary Medicines
• Cosmetics & Personal Care Products
• Herbal & Traditional Medicines
• Food Ingredients & Nutraceuticals
• Essential Oils & Natural Extracts
• Agrochemical Products
• Industrial Chemicals
Why Choose DossierTrans?
✅ Regulatory-focused scientific translation
✅ Native-language scientific reviewers
✅ Consistent terminology across submissions
✅ Authority-ready documentation
✅ Support for regulatory queries and revisions
✅ Strict confidentiality and data protection
African Regulatory Expertise
Our translation and review services support submissions to regulatory authorities across Africa, including:
North Africa
• Egypt Drug Authority
• Morocco Directorate of Medicines
• Tunisia Directorate of Pharmacy
West Africa
• Nigeria NAFDAC
• Ghana FDA
• Ivory Coast DPM
• Senegal Directorate of Pharmacy
East Africa
• Tanzania TMDA
• Kenya Pharmacy and Poisons Board
• Ethiopia EFDA
• Uganda NDA
Southern Africa
• South Africa SAHPRA
• Zambia ZAMRA
• Zimbabwe MCAZ
• Botswana BoMRA
Our Commitment
At DossierTrans, we understand that accurate translation is critical for regulatory acceptance.
Even small translation errors can lead to regulatory delays, additional queries, or rejection.
That is why we provide precision-driven, regulator-acceptable translations specifically designed for African regulatory submissions.
Our mission is to help manufacturers achieve smooth product registrations and faster approvals across African markets.