DossierTrans

China Dossier & Technical Document Translation Services

Accurate. NMPA-Compliant. Authority-Ready.

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

We support Chinese manufacturers, MAHs, importers, exporters, CROs, regulatory consultants, and global companies targeting the China market with precise, technically accurate, and NMPA-acceptable translations, ensuring smooth submissions, technical reviews, inspections, approvals, and lifecycle compliance in China.

Who We Are

DossierTrans is a specialized regulatory translation service provider for the China market, focused exclusively on scientific, pharmaceutical, medical device, food, and technical documentation.

All translations are performed and reviewed by subject-matter experts, regulatory professionals, and native-language technical reviewers—not general translators.

We ensure that translated dossiers consistently maintain:

• Scientific accuracy
• Regulatory intent
• Terminology consistency
• Compliance with NMPA / Chinese Pharmacopoeia / official guidance expectations

China Regulatory Alignment

Our services are fully aligned with the requirements of:

• National Medical Products Administration (NMPA)
• Center for Drug Evaluation (CDE), NMPA
• Center for Medical Device Evaluation (CMDE)
• National Health Commission (NHC)
• State Administration for Market Regulation (SAMR)
• Chinese Pharmacopoeia Commission (ChP)
• China Customs & Port Health Authorities

Our Core Services – China

📘 Dossier & Technical Document Translation

• China-specific CTD / eCTD / non-CTD dossier formats
• Module 1–5 translations for IND, NDA, BLA, generic & DMF submissions
• Chinese-language SmPC, PIL, IFU, labels & packaging text
• Medical device technical documentation
• Stability studies, validation & analytical reports
• SOPs, specifications, COAs, SDS, MSDS & technical files
• Import registration, MAH documentation & manufacturing site information

🔍 Review of Translated Dossiers

• Technical and scientific review of Chinese translations
• Cross-verification with source (English or original language) dossiers
• Identification of terminology inconsistencies, mistranslations & regulatory gaps
• Alignment with Chinese Pharmacopoeia (ChP), NMPA guidance & ICH-adopted standards

🛡️ Post-Submission Regulatory Query Handling – China

• CDE / NMPA technical deficiency questions related to translated content
• Scientific clarification and China-style regulatory re-wording support
• Revised translations responding to official review comments
• Coordination with local agents, MAHs, CROs & regulatory consultants in China

Languages We Support (China-Focused)

We provide professional, native-level regulatory translations relevant to Chinese submissions:

🌍 International Languages → Chinese

• English ↔ Chinese (Simplified)
• English ↔ Chinese (Traditional)
• Japanese ↔ Chinese
• Korean ↔ Chinese

🇨🇳 Regulatory Language Support

• Chinese (Simplified) – mandatory for NMPA submissions
• English – structured to support bilingual regulatory review

All translations are reviewed by native Chinese scientific and regulatory experts experienced with NMPA submissions.

Industries We Serve – China

We provide specialized translation and review services for:

• Pharmaceuticals & APIs
• Biologics, Vaccines & Biosimilars
• Medical Devices & IVDs
• Cosmetics & Personal Care Products
• Food, Health Foods & Nutraceuticals
• Chemicals & Specialty Materials

Why Choose DossierTrans for China?

✅ China-regulatory-focused translation (not generic translation)
✅ Expertise in NMPA, CDE & CMDE documentation
✅ Native Chinese scientific & regulatory reviewers
✅ Consistent terminology aligned with Chinese Pharmacopoeia
✅ Authority-ready Chinese dossiers
✅ End-to-end support including post-submission technical queries
✅ Strict confidentiality & data security

Global & China Regulatory Expertise

Our China services support:

• China NMPA registrations & filings
• Import & MAH-related documentation
• Export-support translations for China-manufactured products
• Post-approval changes, renewals & lifecycle management

Our Commitment

At DossierTrans, we understand that a single incorrect Chinese term or regulatory phrase can lead to major delays or rejection by NMPA.

That’s why we deliver precision-driven, regulator-acceptable Chinese translations, aligned with China’s strict regulatory and linguistic expectations—every time.

DossierTrans – Translating Science into Regulatory Approval in China