DossierTrans – Hong Kong

Hong Kong 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 Hong Kong–specific dossiers and technical documents, aligned with Hong Kong regulatory authorities and statutory requirements.

We support Hong Kong 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 Hong Kong.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Hong Kong 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 maintains:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with Hong Kong–specific DOH / CFS / MDCO expectations

Hong Kong Regulatory Alignment

Our services are aligned with the requirements of:

• Department of Health (DoH), Hong Kong SAR
• Drug Office – Pharmaceutical Registration & Regulation
• Chinese Medicines Regulatory Office (CMRO)
• Centre for Food Safety (CFS)
• Medical Device Control Office (MDCO)
• Hong Kong Customs & Excise Department
• Pharmacy and Poisons Ordinance (Cap. 138)
• ISO / IEC 17025-accredited testing laboratories (HOKLAS-recognized)

Our Core Services – Hong Kong

📘 Dossier & Technical Document Translation

• Hong Kong–specific CTD / non-CTD dossier formats
• Administrative & technical dossier translations for DoH submissions
• Labels, package inserts, leaflets & artwork text (English / Chinese compliant)
• Stability studies, analytical validation & study reports
• SOPs, specifications, COAs, SDS & technical documentation
• Import license, product registration & 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 Hong Kong legislation, pharmacopoeial references, and DoH guidance

🛡️ Post-Submission Regulatory Query Handling – Hong Kong

• DoH / CFS / CMRO / MDCO 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 importers

Languages We Support (Hong Kong-Focused)

🌍 International Languages

• English
• French
• German
• Spanish
• Italian
• Portuguese
• Russian
• Arabic
• Japanese
• Korean

🇭🇰 Local & Regional Language Support

• Chinese (Traditional)
• Chinese (Simplified) (where applicable)
• English (Hong Kong regulatory format)

English ↔ Traditional Chinese | Foreign Language ↔ English / Chinese

All translations are reviewed by regulatory experts experienced with Hong Kong DoH, CFS, and MDCO requirements.

Industries We Serve – Hong Kong

• Pharmaceuticals & APIs
• Chinese Medicines & Herbal Products
• Medical Devices
• Cosmetics & Personal Care
• Food & Nutraceutical Ingredients
• Essential Oils & Fragrances
• Chemicals & Industrial Products

Why Choose DossierTrans for Hong Kong?

✅ Hong Kong-regulatory-focused translation (not generic translation)
✅ Expertise in DoH, CFS, CMRO & MDCO documentation
✅ Native-language scientific & regulatory reviewers
✅ Bilingual terminology consistency (English–Chinese)
✅ Authority-ready, inspection-friendly documentation
✅ End-to-end support including post-submission regulatory queries
✅ Strict confidentiality & data security

Global & Hong Kong Regulatory Expertise

Our Hong Kong services support:

• DoH pharmaceutical registration dossiers
• Chinese medicine & medical device submissions
• Import license & customs documentation
• Export-support translations for China, 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 Hong Kong regulatory approval.

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

DossierTrans – Translating Science into Regulatory Approval in Hong Kong

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