DossierTrans

United Arab Emirates Dossier & Technical Document Translation Services

Accurate. MOHAP / DHA / DOH-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, fully aligned with United Arab Emirates regulatory frameworks and statutory requirements.

We support UAE-based manufacturers, importers, distributors, MAHs, free-zone companies, regulatory consultants, CROs, and global companies targeting the UAE and GCC markets with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, approvals, inspections, and lifecycle compliance across the UAE.

Who We Are

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

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and native-language technical reviewers—not general translators.

We ensure that translated dossiers consistently maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with MOHAP / DHA / DOH / GCC regulatory expectations

UAE Regulatory Alignment

Our services are fully aligned with the requirements of:

• Ministry of Health & Prevention (MOHAP) – Federal
• Dubai Health Authority (DHA)
• Department of Health – Abu Dhabi (DOH)
• Emirates Health Services (EHS)
• Gulf Health Council (GHC)
• Gulf Standards Organization (GSO)
• UAE Customs & Port Health Authorities

Our Core Services – United Arab Emirates

📘 Dossier & Technical Document Translation

• UAE- and GCC-specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for drug, biologic & generic registrations
• Arabic-language SmPC, PIL, IFU, labels & packaging text (mandatory)
• Medical device technical documentation (MOHAP / DHA / DOH)
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS, MSDS & technical files
• Import, free-zone registration & marketing authorization documentation

🔍 Review of Translated Dossiers

• Technical and scientific review of Arabic translations
• Cross-verification with source (English or original language) dossiers
• Identification of terminology errors, mistranslations & compliance gaps
• Alignment with UAE MOHAP guidance, GCC harmonized standards, ICH & WHO

🛡️ Post-Submission Regulatory Query Handling – UAE

• MOHAP / DHA / DOH deficiency letters & clarification requests related to translated content
• Scientific clarification and UAE-style regulatory re-wording support
• Revised translations responding to authority observations
• Coordination with local agents, MAHs, free-zone entities & consultants

Languages We Support (UAE-Focused)

We provide professional, native-level regulatory translations relevant to UAE submissions:

🌍 International Languages

• English ↔ Arabic (mandatory)
• English ↔ French
• English ↔ German
• English ↔ Spanish
• English ↔ Chinese

Foreign Language ↔ Arabic | Foreign Language ↔ English

All translations are reviewed by native Arabic scientific and regulatory experts experienced with UAE & GCC submissions.

Industries We Serve – United Arab Emirates

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biologics, Vaccines & Biosimilars
• Medical Devices & IVDs
• Biotechnology & Advanced Therapies
• Clinical Trials & CROs
• Cosmetics & Personal Care Products
• Food Supplements & Nutraceuticals
• Chemicals & Specialty Materials

Why Choose DossierTrans for the UAE?

✅ UAE & GCC–focused regulatory translation (not generic translation)
✅ Expertise in MOHAP, DHA, DOH & GCC documentation
✅ Native Arabic scientific & regulatory reviewers
✅ Consistent terminology aligned with UAE regulatory expectations
✅ Authority-ready documentation
✅ End-to-end support including post-submission queries
✅ Strict confidentiality & data security

Global & UAE Regulatory Expertise

Our UAE services support:

• MOHAP registrations & GCC submissions
• Import & free-zone compliance documentation
• Export-support translations for GCC, EU, US & ROW markets
• Post-approval changes, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single incorrect Arabic regulatory term can delay or block a UAE approval.

That’s why we deliver precision-driven, regulator-acceptable translations, aligned with UAE and GCC regulatory and linguistic expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in the United Arab Emirates