DossierTrans

Rwanda 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 Rwanda-specific dossiers and technical documents, aligned with the Rwanda Food and Drug Authority (Rwanda FDA) and the East African Community (EAC) regional guidelines.

We support manufacturers, exporters, importers, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, registrations, and approvals in the Republic of Rwanda.

Who We Are

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

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and technical reviewers, ensuring deep understanding of the source material and alignment with Rwanda FDA and EAC requirements.

Rwandan Regulatory Alignment

Our services are aligned with the requirements of:

• Rwanda Food and Drug Authority (Rwanda FDA) (The principal national regulatory authority)

• Ministry of Health (MoH)

• East African Community (EAC) harmonized guidelines for registration (EAC Medicine Registration Guidelines).

• Requirements for product registration (MAA) and import licensing.

Language Mandate: English, Kinyarwanda, and French

Rwanda is multilingual, but English is often the primary language for technical regulatory dossiers, while Kinyarwanda and French are essential for consumer-facing materials.

Document TypeLanguage RequirementCompliance NoteTechnical Dossier (CTD)English PreferredModules 2-5 of the dossier are typically submitted in English, aligning with EAC harmonization standards. Non-English source documents must be translated into English or French.Labelling & Patient Information Leaflets (PIL)Bilingual or Trilingual (English & Kinyarwanda/French)The Rwanda FDA requires that consumer information (labels, PILs) be provided in at least English and Kinyarwanda, and often French as well, depending on the product and target group. Accurate translations of safety warnings into Kinyarwanda are critical.CertificatesEnglish or FrenchLegal and administrative documents (CPP, FSC) must be submitted in English or French. If the source language is different, an official translation into English or French is required.

Our Core Services – Rwanda

📘 Dossier & Technical Document Translation

• Translation of modules/sections for Rwanda FDA submissions, often in the EAC-CTD format.

• Trilingual Translation: Preparation of PILs, SmPCs, and Labelling text in English, Kinyarwanda, and French to meet local and regional requirements.

• Translation of technical reports (quality, stability) from non-English sources into clear regulatory English.

🔍 Review of Translated Dossiers

• Technical and scientific review of English, Kinyarwanda, and French documentation.

• Verification of terminology consistency across all three languages, especially for dosage instructions and safety warnings.

• Alignment with Rwanda FDA and EAC guidelines.

🛡️ Post-Submission Regulatory Query Handling – Rwanda

• Assistance in addressing Rwanda FDA queries, particularly those related to the clarity and accuracy of the Kinyarwanda/French patient information.

• Scientific clarification and regulatory re-wording support.

Why Choose DossierTrans for Rwanda?

✅ Rwanda FDA and EAC-regulatory-focused translation.

✅ Expertise in managing the trilingual requirements (English, Kinyarwanda, French) for consumer materials.

✅ Scientific reviewers ensuring pharmaceutical and technical accuracy in all required languages.

✅ Support for EAC regional dossier submission standards.

Our Commitment

DossierTrans delivers high-precision, multilingual translations that ensure scientific integrity and meet the rigorous compliance standards of the Rwanda FDA, facilitating your product's market access in Rwanda and the broader East African Community.

DossierTrans – Translating Science into Regulatory Approval in Rwanda.