DossierTrans
China Dossier & Technical Document Translation Services
精准. 符合法规. 权威认可. (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 China-specific dossiers and technical documents, aligned with the National Medical Products Administration (NMPA) and other national statutory requirements.
We support multinational companies, manufacturers, exporters, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and approvals in the People's Republic of China (PRC).
Who We Are
DossierTrans is a specialized regulatory translation service provider for the Chinese market, focused exclusively on scientific, pharmaceutical, medical device, 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:
科学准确性 (Scientific accuracy)
法规意图 (Regulatory intent)
术语一致性 (Terminology consistency)
满足 NMPA 和 China Pharmacopoeia 要求
Chinese Regulatory Alignment
Our services are aligned with the requirements of:
国家药品监督管理局 (NMPA) / National Medical Products Administration (formerly CFDA)
国家卫生健康委员会 (NHC) (National Health Commission)
海关总署 (GACC) (General Administration of Customs)
中国药典 (ChP) (Chinese Pharmacopoeia)
Requirements for IND, NDA/BLA, & Marketing Authorization submissions
Our Core Services – China
📘 Dossier & Technical Document Translation (申报资料与技术文件翻译)
中国特定格式的注册文件翻译 (e.g., Module 1 sections)
CTD/eCTD 模块翻译 (Module 2, 3, 4, 5)
药品说明书 (SmPC), 患者信息和标签 (Labels) (符合 NMPA 要求)
质量研究, 稳定性, 临床研究报告 (Quality, Stability, Clinical Study Reports)
标准操作程序 (SOPs), 质量标准, COA, SDS & 技术文件
医疗器械注册资料 (Medical Device Registration Documentation)
🔍 Review of Translated Dossiers (已翻译资料审核)
对已翻译文件的技术和科学审查
与原始资料（如英文版）进行交叉验证
识别术语错误、不一致和法规差距
确保与 NMPA 要求 和中国药典术语一致
🛡️ Post-Submission Regulatory Query Handling – China (上市后法规问询支持)
NMPA 审评中心 (CDE/CMDE) 关于翻译内容的问询
科学澄清和法规措辞支持
根据机构意见提供修改后的翻译
协助申请人、顾问和当地代理人之间的协调
Languages We Support (China-Focused)
We provide professional, native-level regulatory translations relevant to Chinese submissions and technical documentation:
🌍 International Languages (for Import & Export)🇨🇳 Official Language Support* English* 简体中文 (Simplified Chinese) (Standard for NMPA submissions)* German* 繁體中文 (Traditional Chinese - on request)* JapaneseEnglish ↔ Simplified Chinese | Simplified Chinese ↔ English* Korean* French
All translations are performed by scientific and regulatory experts familiar with NMPA regulations and Chinese technical terminology.
Industries We Serve – China
We provide specialized translation and review services for:
药品和原料药 (Pharmaceuticals & APIs)
医疗器械和 IVD (Medical Devices & IVDs)
化妆品和个人护理 (Cosmetics & Personal Care)
传统中药和天然药物 (Traditional Chinese Medicine & Natural Products)
食品和保健食品 (Food & Health Food)
农用化学品和工业化学品 (Agrochemicals & Industrial Chemicals)
Why Choose DossierTrans for China?
✅ 专注于 NMPA 法规 的专业翻译 (非通用翻译)
✅ 熟悉 NMPA, CDE, 和 CMDE 申报要求和标准
✅ 科学背景的母语审校人员
✅ 确保在中国申报资料中术语的高度一致性
✅ 资料准备符合权威机构要求 (Authority-ready)
✅ 全流程支持，包括上市后法规问询
✅ 严格保密和数据安全
Our Commitment
在 DossierTrans, 我们深知一个翻译错误可能会导致 中国监管审批的延误或被拒。因此，我们始终提供精准、被监管机构接受的翻译，以符合 中国法规 的要求。
DossierTrans – Translating Science into Regulatory Approval in China.