DossierTrans

Oman 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 Oman-specific dossiers and technical documents, aligned with the Directorate General of Pharmaceutical Affairs and Drug Control (DG PAC) / Ministry of Health (MoH) 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 Sultanate of Oman.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Omani 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/DGPAC and GCC expectations

Omani Regulatory Alignment

Our services are aligned with the requirements of:

• Directorate General of Pharmaceutical Affairs and Drug Control (DGPAC), Ministry of Health (MoH)

• GCC Central Registration requirements and guidelines

• Public Authority for Consumer Protection (PACP)

• Oman Customs and Port Health authorities

Our Core Services – Oman

📘 Dossier & Technical Document Translation

• GCC/Oman CTD / non-CTD dossier formats

• Translation of modules/sections for DGPAC submissions

• Product Information: Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and Labelling text (Oman-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/DGPAC guidelines and applicable regulatory references

🛡️ Post-Submission Regulatory Query Handling – Oman

• MoH/DGPAC 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 (Oman and GCC Focused)

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

🌍 International Languages (for Import & Export)🇴🇲 Official and Regional Language Support* English* Arabic (Official Language)* FrenchEnglish ↔ Arabic | Arabic ↔ English* German* Swahili (historical/trade link)* Chinese* Farsi/Persian* Russian

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

Industries We Serve – Oman

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 Oman?

✅ Oman/GCC-regulatory-focused translation

✅ Expertise in MoH/DGPAC 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 an Omani regulatory approval. That’s why we deliver precision-driven, regulator-acceptable translations aligned with Omani compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Oman.