DossierTrans

Kuwait 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 Kuwait-specific dossiers and technical documents, aligned with the Ministry of Health (MoH) Drug and Food Control Department (DFCD) and Gulf Cooperation Council (GCC) standards.

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

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Kuwaiti 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, not general translators.

We ensure that translated dossiers maintain:

• Scientific accuracy

• Regulatory intent

• Terminology consistency

• Compliance with MoH/DFCD and GCC expectations

Kuwaiti Regulatory Alignment

Our services are aligned with the requirements of:

• Ministry of Health (MoH) - Drug and Food Control Department (DFCD)

• GCC Central Registration requirements and guidelines

• Kuwait Public Authority for Industry (PAI)

• Customs and Port Health authorities

Our Core Services – Kuwait

📘 Dossier & Technical Document Translation

• GCC/Kuwait CTD / non-CTD dossier formats

• Translation of modules/sections for DFCD submissions

• Product Information: Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and Labelling text (Kuwait-compliant)

• Stability, validation & study reports

• SOPs, specifications, COAs, SDS & technical files

• Import and commercial registration documentation

🔍 Review of Translated Dossiers

• Technical and scientific review of translated documents

• Cross-verification with source (e.g., English) dossiers

• Identification of terminology errors, inconsistencies & compliance gaps

• Alignment with official MoH/DFCD guidelines and applicable regulatory references

🛡️ Post-Submission Regulatory Query Handling – Kuwait

• MoH/DFCD queries related to translated content

• Scientific clarification and regulatory re-wording support

• Revised translations as per authority observations

• Coordination with applicants, consultants, and local distributors/agents

Languages We Support (Kuwait and GCC Focused)

We provide professional, native-level regulatory translations relevant to Kuwaiti submissions and GCC regulatory processes:

🌍 International Languages (for Import & Export)🇰🇼 Official and Regional Language Support* English* Arabic (Official Language)* FrenchEnglish ↔ Arabic | Arabic ↔ English* German* Other regional languages (on request)* Chinese* Farsi/Persian* Russian

All translations are reviewed by scientific and regulatory experts familiar with Kuwaiti and GCC regulations.

Industries We Serve – Kuwait

We provide specialized translation and review services for:

• Pharmaceuticals & APIs

• Medical Devices & IVDs

• Cosmetics & Personal Care

• Food Supplements & Nutraceuticals

• General Industrial/Technical Products

Why Choose DossierTrans for Kuwait?

✅ Kuwaiti/GCC-regulatory-focused translation

✅ Expertise in MoH/DFCD documentation and standards

✅ Native-language scientific reviewers

✅ Terminology consistency across GCC submissions

✅ Authority-ready documentation

✅ End-to-end support including post-approval queries

✅ Strict confidentiality & data security

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a Kuwaiti regulatory approval. That’s why we deliver precision-driven, regulator-acceptable translations aligned with Kuwaiti compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Kuwait.