DossierTrans – Thailand

Thailand Dossier & Technical Document Translation Services

Accurate. Regulatory-Compliant. Authority-Ready.

DossierTrans, a scientific arm of Zoesoe Exports Pvt Ltd, provides end-to-end translation, technical review, and regulatory query support for Thailand-specific dossiers and technical documents, aligned with Thai regulatory authorities and statutory requirements.

We support Thai manufacturers, importers, exporters, marketing authorization holders, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and regulatory approvals in Thailand.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Thailand 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 every translated dossier preserves:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Thailand-specific Thai FDA / MoPH expectations

Thailand Regulatory Alignment

Our services are aligned with the requirements of:

• Thai Food and Drug Administration (Thai FDA)
• Ministry of Public Health (MoPH), Thailand
• Drug Act B.E. 2510 and related regulations
• ASEAN Harmonized Technical Requirements (ACTD / ACTR)
• Thai Industrial Standards Institute (TISI)
• Thai Customs Department
• Other applicable import & export regulatory authorities in Thailand

Our Core Services – Thailand

📘 Dossier & Technical Document Translation

• Thailand-specific ACTD / non-ACTD dossier formats
• Administrative & technical dossier translations for Thai FDA submissions
• Labels, package inserts, leaflets & artwork text (Thai language–compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Product registration, import license & export documentation

🔍 Review of Translated Dossiers

• Scientific and technical review of translated documents
• Cross-verification with source-language dossiers
• Identification of terminology errors, inconsistencies & regulatory gaps
• Alignment with Thai FDA guidelines, ACTD references, and MoPH requirements

🛡️ Post-Submission Regulatory Query Handling – Thailand

• Thai FDA / MoPH queries related to translated content
• Scientific clarification and regulatory re-wording support
• Revised translations based on authority observations
• Coordination with applicants, consultants, local agents, and distributors

Languages We Support (Thailand-Focused)

🌍 International Languages

• English
• French
• German
• Spanish
• Italian
• Portuguese
• Russian
• Arabic
• Chinese (Simplified & Traditional)
• Japanese
• Korean

🇹🇭 Local & Regional Language Support

• Thai
• English (Thailand regulatory format)

English ↔ Thai | Foreign Language ↔ English / Thai

All translations are reviewed by regulatory experts experienced with Thai FDA and ASEAN submission requirements.

Industries We Serve – Thailand

• Pharmaceuticals & APIs
• Medical Devices
• Vaccines & Biologicals
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Herbal & Traditional Medicines
• Essential Oils & Fragrances
• Agrochemicals
• Industrial & Specialty Chemicals

Why Choose DossierTrans for Thailand?

✅ Thailand-regulatory-focused translation (not generic translation)
✅ Proven expertise in Thai FDA & ASEAN ACTD documentation
✅ Native-language scientific & regulatory reviewers
✅ Terminology consistency across Thailand submissions
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security

Global & Thailand Regulatory Expertise

Our Thailand services support:

• Thai FDA product registration & import authorization dossiers
• Manufacturing & marketing authorization documentation
• Export-support translations for ASEAN & ROW markets
• Post-approval variations, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single mistranslated sentence can delay or reject a Thai FDA approval.

That’s why we deliver precision-driven, regulator-acceptable translations, fully aligned with Thailand compliance expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in Thailand

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