DossierTrans

Taiwan Dossier & Technical Document Translation Services

準確. 符合法規. 權威認可. (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 Taiwan-specific dossiers and technical documents, aligned with the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare (MOHW).

We support manufacturers, exporters, and regulatory teams with precise, technically accurate, and authority-acceptable translations, ensuring smooth submissions, inspections, and approvals in Taiwan (Republic of China, R.O.C.).

Who We Are

DossierTrans is a specialized regulatory translation service provider for the Taiwanese 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, ensuring deep understanding of the source material's scientific content and the TFDA's regulatory requirements.

We ensure that translated dossiers maintain:

• 科學準確性 (Scientific accuracy)

• 法規意圖 (Regulatory intent)

• 術語一致性 (Terminology consistency)

• 滿足 TFDA 和 中華藥典 要求

Taiwan Regulatory Alignment

Our services are aligned with the requirements of:

• 衛生福利部食品藥物管理署 (TFDA) / Taiwan Food and Drug Administration

• 財團法人醫藥品查驗中心 (CDE) / Center for Drug Evaluation

• Requirements for NDA, ANDA, and Medical Device registrations

• Compliance with Traditional Chinese language mandates

Our Core Services – Taiwan

📘 Dossier & Technical Document Translation (申報資料與技術文件翻譯)

• CTD/eCTD 格式的註冊文件翻譯 (所有模塊，特别是行政/區域部分)

• 藥品說明書 (SmPC), 病患資訊 (PIL), 和標籤 (Labels) (必須是繁體中文)

• 品質研究, 穩定性, 臨床研究報告 (Quality, Stability, Clinical Study Reports)

• 醫療器材註冊資料翻譯 (符合《醫療器材管理法》)

• SOPs, 規格書, COA, SDS & 技術文件

• 授權書 (Authorization Letter) 和自由銷售證明書 (FSC) 的中文翻譯和公證準備

🔍 Review of Translated Dossiers (已翻譯資料審核)

• 對已翻譯文件的技術和科學審查 (確保使用 TFDA 慣用術語)

• 與原始資料（如英文版）進行交叉驗證

• 識別術語錯誤、不一致和法規差距

• 確保與 TFDA 要求 和中華藥典術語一致

🛡️ Post-Submission Regulatory Query Handling – Taiwan (上市後法規問詢支持)

• TFDA/CDE 審查中心關於翻譯內容的問詢 (Query Responses)

• 協助科學澄清和法規措辭支持

• 根據機構意見提供修改後的翻譯

• 協助與當地代理人和授權代表之間的溝通協調

Language Mandate: Traditional Chinese

A critical compliance requirement for TFDA submissions is the mandatory use of Traditional Chinese for all consumer-facing documents and key administrative forms.

Document TypeLanguage RequirementSubmission DetailsAdministrative/Covering DocumentsTraditional Chinese MandatoryApplication forms, cover letters, and official statements must be in Chinese.Labelling & PIL/IFUTraditional Chinese MandatoryPatient Information Leaflets (PIL), Instructions for Use (IFU) for medical devices, and primary packaging labels must be fully translated into Traditional Chinese.Technical DossierEnglish Accepted (with caveats)Modules 2-5 of the CTD can generally be submitted in English, but official translations (Traditional Chinese) of certain key sections may be requested by TFDA/CDE. Non-Chinese/English documents must include a Chinese or English translation.

Why Choose DossierTrans for Taiwan?

✅ 專注於 TFDA 法規 的專業翻譯，並使用繁體中文

✅ 熟悉 TFDA 藥品和醫療器械的申報要求

✅ 擁有科學背景和TFDA法規經驗的母語審校人員

✅ 確保所有公開文件和行政文件的強制性中文翻譯的合規性

✅ 嚴格保密和數據安全

Our Commitment

在 DossierTrans, 我們提供的翻譯服務旨在加速您的產品在台灣的上市流程。我們專注於提供符合 TFDA 嚴格要求 的精準、專業且具備科學背景的技術文件翻譯。

DossierTrans – Translating Science into Regulatory Approval in Taiwan.