DossierTrans

UAE 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 UAE-specific dossiers and technical documents. Our services are aligned with the new federal authority, the Emirates Drug Establishment (EDE), the Ministry of Health and Prevention (MoHAP), and Gulf Cooperation Council (GCC) standards.

We specialize in precise, technically accurate, and bilingual (Arabic/English) translations, crucial for market authorization, inspections, and smooth approvals across the United Arab Emirates.

Key Regulatory Authority: Emirates Drug Establishment (EDE)

Established in 2023, the Emirates Drug Establishment (EDE) is the federal authority responsible for regulating the entire lifecycle of medical and pharmaceutical products, including:

• Pharmaceuticals

• Medical Devices

• Biologics

• Food Supplements and Cosmetics (often in coordination with MoHAP/local authorities)

MoHAP and local authorities (DHA in Dubai, DoH in Abu Dhabi) also play key roles in licensing, inspections, and product registration oversight.

Our Core Services – UAE

📘 Dossier & Technical Document Translation

• GCC/UAE CTD/eCTD dossier formats

• Translation of Product Information (PI): Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and Labelling/Artwork text into Mandatory Arabic and English.

• Legalized Arabic Translations: Preparation of authenticated Arabic translations for documents required by EDE/MoHAP (e.g., Certificate of Pharmaceutical Product (CPP), Free Sale Certificates (FSC), Legalized Letters).

• Quality Control (QC) reports, Stability Data, and Study Summaries (Modules 2-5).

• Instructions for Use (IFU) and User Manuals for Medical Devices (Mandatory Arabic/English).

🔍 Review of Translated Dossiers

• Technical and scientific review of Arabic and English documentation.

• Cross-verification of Arabic labels, PILs, and SmPCs against the submitted English dossier to ensure 1:1 consistency (a common cause for query/rejection).

• Alignment with EDE/MoHAP/GCC terminology and formatting guidelines.

🛡️ Post-Submission Regulatory Query Handling – UAE

• Assistance with EDE/MoHAP queries related to translated content (e.g., Arabic labeling discrepancies).

• Scientific clarification and regulatory re-wording support in both Arabic and English.

• Revised translations based on authority observations.

Mandatory Language Requirements (Arabic & English)

For consumer-facing products (Pharmaceuticals, Medical Devices, Supplements, Cosmetics), the UAE mandates bilingual documentation, with Arabic being critical for compliance.

Document TypeLanguage RequirementCompliance NoteLabelling (Outer/Inner)Mandatory Dual Language (Arabic & English)All essential information (product name, ingredients, dosage, warnings, batch/expiry) must be clear and legible in both languages. Arabic translation is non-negotiable for market release.Patient Information Leaflet (PIL)Mandatory Dual Language (Arabic & English)Must include full instructions, side effects, and warnings in both languages.Controlled DrugsStrict Arabic/EnglishHighly regulated; labeling and prescribing information requires exact, audited Arabic translation.Dossier (CTD)English Accepted (for Technical Modules)Modules 2, 3, 4, 5 (Quality, Non-Clinical, Clinical) are typically accepted in English, but Module 1 (Administrative/Regional) requires specific Arabic translations and authenticated documents.

Industries We Serve – UAE

We provide specialized translation and review services for:

• Pharmaceuticals & APIs (Conventional, Generics, Biologics)

• Medical Devices & IVDs

• Food Supplements & Nutraceuticals

• Medicated Cosmetics

• Controlled Substances

Why Choose DossierTrans for the UAE?

✅ EDE/MoHAP/GCC-regulatory-focused translation

✅ Expertise in managing mandatory dual-language documentation.

✅ Native Arabic scientific reviewers with regulatory experience.

✅ Strict terminology consistency between source (English) and target (Arabic) dossiers.

✅ Support for legalized translations and artwork mock-up compliance.

Our Commitment

At DossierTrans, we minimize the risk of registration delays due to language and labeling errors. We ensure your documentation is precise, compliant with EDE and MoHAP standards, and ready for market entry in the UAE.

DossierTrans – Translating Science into Regulatory Approval in the UAE