DossierTrans

Bahrain 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 Bahrain-specific dossiers and technical documents, aligned with the National Health Regulatory Authority (NHRA) and other 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 Kingdom of Bahrain.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Bahraini market, focused exclusively on scientific, pharmaceutical, 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 NHRA and GCC expectations

Bahraini Regulatory Alignment

Our services are aligned with the requirements of:

• National Health Regulatory Authority (NHRA)

• GCC Central Registration requirements and guidelines

• Ministry of Industry and Commerce (MOIC)

• Customs and Port Health authorities

Our Core Services – Bahrain

📘 Dossier & Technical Document Translation

• GCC/Bahrain CTD / non-CTD dossier formats

• Translation of modules/sections for NHRA submissions (e.g., Quality, Non-Clinical, Clinical)

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

🛡️ Post-Submission Regulatory Query Handling – Bahrain

• NHRA 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 (Bahrain and GCC Focused)

We provide professional, native-level regulatory translations relevant to Bahraini 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 Bahraini and GCC regulations.

Industries We Serve – Bahrain

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 Bahrain?

✅ NHRA/GCC-regulatory-focused translation

✅ Expertise in NHRA 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 Bahraini regulatory approval. That’s why we deliver precision-driven, regulator-acceptable translations aligned with NHRA compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Bahrain.