DossierTrans
Qatar 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 Qatar-specific dossiers and technical documents, aligned with the Ministry of Public Health (MoPH) Department of Drug Control and Pharmacy 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 Qatar.
Who We Are
DossierTrans is a specialized regulatory translation service provider for the Qatari 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 MoPH/Drug Control and GCC expectations
Qatari Regulatory Alignment
Our services are aligned with the requirements of:
Ministry of Public Health (MoPH) - Drug Control and Pharmacy Department
GCC Central Registration requirements and guidelines
Qatar General Organization for Standards and Metrology (QS)
Customs and Port Health authorities
Our Core Services – Qatar
📘 Dossier & Technical Document Translation
GCC/Qatar CTD / non-CTD dossier formats
Translation of modules/sections for MoPH submissions
Product Information: Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and Labelling text (Qatar-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 MoPH guidelines and applicable regulatory references
🛡️ Post-Submission Regulatory Query Handling – Qatar
MoPH/Drug Control 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 (Qatar and GCC Focused)
We provide professional, native-level regulatory translations relevant to Qatari submissions and GCC regulatory processes:
🌍 International Languages (for Import & Export)🇶🇦 Official and Regional Language Support* English* Arabic (Official Language)* FrenchEnglish ↔ Arabic | Arabic ↔ English* German* Persian/Farsi* Chinese* Indian languages (due to expatriate population)* Russian
All translations are reviewed by scientific and regulatory experts familiar with Qatari and GCC regulations.
Industries We Serve – Qatar
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 Qatar?
✅ Qatari/GCC-regulatory-focused translation
✅ Expertise in MoPH/Drug Control 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 Qatari regulatory approval. That’s why we deliver precision-driven, regulator-acceptable translations aligned with Qatari compliance expectations—every time.
DossierTrans – Translating Science into Regulatory Approval in Qatar.
Would you like to know the dual-language requirements (English and Arabic) for the patient information and labeling submitted to the Qatari MoPH?
Yes, I can certainly elaborate on the dual-language requirements for patient information and labeling in Qatar, as this is a critical component of regulatory compliance.
The Ministry of Public Health (MoPH) in Qatar, through the Drug Control and Pharmacy Department, strictly mandates dual-language documentation for consumer-facing materials, primarily English and Arabic.
📝 Key Language Requirements for Qatar Submissions
Document TypeLanguage RequirementCompliance DetailsLabelling (Outer Packaging)Mandatory Dual Language: Arabic and EnglishEssential information must be clearly printed in both languages. This includes, but is not limited to, the product name, active ingredient, strength, storage conditions, batch number, and expiration dates.Patient Information Leaflet (PIL)Arabic Translation RequiredWhile the primary submission/source is often in English (as part of the GCC/eCTD dossier), the final approved Patient Information Leaflet (PIL) for dispensing must be fully translated into Arabic.Safety WarningsArabic is ParamountAll usage directions, warnings, and safety phrases (e.g., "For external use only," necessary disclaimers like "This is not a medicine" for supplements) must be accurately translated into Arabic.Braille InformationMandatory Dual Braille: Arabic and EnglishThe MoPH has issued guidelines requiring the name of the medicine, its active ingredient, and strength to be printed in Braille in both Arabic and English on the outer packaging. Note: Full compliance for all products is generally phased in.General DocumentationEnglish Accepted (for Dossier)Technical and administrative parts of the eCTD/dossier (Modules 2-5) are typically submitted in English, but Module 1 (administrative/regional information) requires specific Arabic documents or translations.
The Critical Role of Accurate Arabic Translation
Regulatory bodies in Qatar place high scrutiny on the Arabic content. Common reasons for rejection or delay include:
Translation Errors: Incorrect or non-standard Arabic terminology, particularly in safety warnings or instructions.
Misleading Claims: Using Arabic words equivalent to "safe," "cure," or "guaranteed" for products like cosmetics or supplements is prohibited unless explicitly justified and approved.
Missing Disclaimers: Failure to include mandatory Arabic disclaimers (e.g., for dietary supplements).
DossierTrans specializes in using MoPH-approved language templates and employing reviewers with a scientific and regulatory background to ensure the Arabic translation maintains the regulatory intent and is compliant with both GCC and Qatari national standards.