DossierTrans-Asia

Global Dossier & Technical Document Translation Services for Asian Regulatory Markets

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 dossiers and technical documents for Asian regulatory markets.

We support pharmaceutical, nutraceutical, herbal, cosmetic, and chemical manufacturers exporting to Asia with technically accurate, regulatory-compliant translations required for submissions to Asian regulatory authorities.

Our services help ensure smooth regulatory submissions, faster approvals, and reduced regulatory queries.

Who We Are

DossierTrans is a specialized regulatory translation service provider dedicated to scientific, pharmaceutical, and technical documentation for Asian regulatory submissions.

Unlike general translation agencies, our work is performed by:

• Regulatory affairs professionals
• Pharmaceutical scientists
• Technical document specialists
• Native-language scientific reviewers

This ensures that translated dossiers maintain:

• Scientific accuracy
• Regulatory intent
• Technical terminology consistency
• Compliance with country-specific MOH / FDA requirements

Our Core Services

📘 Dossier & Technical Document Translation

We provide translation of regulatory dossiers submitted to Asian health authorities.

Our services include:

• CTD, eCTD, ACTD & country-specific dossier formats
• Module 1–5 dossier translations
• Product information translation (SmPC, PIL, labels, artwork text)
• Stability study reports & analytical validation reports
• Clinical and non-clinical reports
• Technical files, SOPs, specifications & COAs
• Safety Data Sheets (SDS)

🔍 Scientific Review of Translated Dossiers

Translation alone is not enough for regulatory submission. We perform technical review of translated documents to ensure regulatory acceptability.

Our review includes:

• Cross-verification with original English dossier
• Identification of terminology errors and inconsistencies
• Correction of scientific and regulatory interpretation issues
• Alignment with authority-approved reference documents

🛡️ Post-Submission Regulatory Query Handling

Many regulatory authorities raise queries related to translated documents during dossier evaluation.

We provide full support for:

• MOH / FDA queries related to translated content
• Scientific clarification and re-wording
• Updated translations as per authority comments
• Coordination with applicants, regulatory agents and partners

Asian Languages We Support

We provide professional regulatory translations for Asian regulatory submissions.

🌏 East Asia

• Chinese (Simplified & Traditional)
• Japanese
• Korean

🌏 ASEAN Countries

• Thai
• Vietnamese
• Indonesian
• Malay
• Filipino (Tagalog)

🌏 South Asia

• Hindi
• Bengali
• Sinhala
• Nepali

🌏 Middle East (Asia Region)

• Arabic
• Turkish
• Persian (Farsi)
• Hebrew

🌏 Central Asia

• Russian
• Kazakh
• Uzbek

Translation Direction

English ↔ Local Language
Local Language ↔ English

All translations undergo scientific and regulatory review before final delivery.

Industries We Serve

Our translation services support regulatory submissions for:

• Pharmaceutical Products & APIs
• Cosmetics & Personal Care Products
• Herbal & Ayurvedic Products
• Traditional Medicines
• Food Ingredients & Nutraceuticals
• Essential Oils & Natural Extracts
• Agrochemical Products
• Industrial Chemicals

Why Choose DossierTrans?

✅ Regulatory-focused scientific translation
✅ Native-language scientific reviewers
✅ Terminology consistency across dossiers
✅ Authority-ready documentation
✅ Support for regulatory queries
✅ Confidential and secure document handling

Asian Regulatory Expertise

Our translation and review services support regulatory submissions to:

ASEAN Region

• Thailand FDA
• Malaysia NPRA
• Indonesia BPOM
• Vietnam DAV
• Philippines FDA
• Singapore HSA

South Asia

• India CDSCO
• Bangladesh DGDA
• Sri Lanka NMRA
• Nepal DDA

East Asia

• China NMPA
• Japan PMDA
• Korea MFDS

Middle East (Asian Region)

• UAE MOH
• Saudi FDA
• Oman MOH
• Qatar MOH
• Kuwait MOH

Our Commitment

At DossierTrans, we understand that a single translation error can delay regulatory approval.

That is why we deliver precision-driven, regulator-acceptable translations designed specifically for Asian regulatory authorities.

Our mission is to help manufacturers submit compliant dossiers, reduce regulatory queries, and achieve faster product approvals across Asia.