Dedicated to Medical Translation, Safeguarding Human Health

As a professional translation service provider with nearly 15 years of experience in the bioscience and medical industries, our life sciences translation project team includes translators with deep subject-matter expertise, a comprehensive quality assurance system, and extensive hands-on project experience, fully meeting the rigorous academic requirements of the life sciences and medical fields. In addition, we obtained ISO 9001 Quality Management System certification and ISO 17100 international translation quality certification in 2016, and became a member of the Translators Association of China and the American Translators Association in the same year. To date, we have provided language services to many well-known biotechnology and medical technology companies in China and abroad, and have established long-term partnerships with multiple Fortune Global 500 companies, including Pfizer, Sanofi, Siemens Healthineers, Novartis, and GE Healthcare, providing translation and localization services for technical documents, registration submissions, and other materials related to products launched in the Chinese market.

  • Medical Devices

    ·Professional Manuals and Documentation

    Including medical device manuals, instructions for use (IFU), installation manuals, user manuals, and medical device graphical user interfaces (GUI).

    ·Experimental Procedures and Patent Applications

    Including experimental reports, surgical equipment patents, and regulatory documents for equipment manufacturing.

    ·Others

    Including medical seminars and summits, advertising and website promotional materials, educational and training materials, and related literature.

  • Pharmaceutical, Medical, and Biological Research Technologies

    ·Pharmaceutical Research

    Product characteristics, quality standards, manufacturing processes, process validation, method validation, stability studies, pharmacological studies, pharmacodynamic studies, toxicological study reports, pharmaceutical patent application materials, IND/NDA/BLA/ANDA submissions, new drug application dossiers (including certification materials for CE, FDA, CFDA, etc.), and application-related materials for traditional Chinese medicine, etc.

    ·Clinical Research

    Clinical study protocols, investigator's brochures, clinical study reports, patient-reported outcomes (PRO), CRFs, ICFs, ethics committee approvals, safety study reports, clinical literature, etc.

  • Clinical Trials

    ·Clinical Trial Protocols

    Case Report Forms (CRF), electronic Case Report Forms (eCRF), clinical trial authorizations, investigator's brochures, investigational drug labels, and other clinical documents.

    ·Trial Patient Information

    Informed Consent Forms (ICF)
    Patient Information Sheets (PIS)
    Patient Safety Cards
    Clinical trial authorization documents, patient diaries, and electronic diaries

Service Advantages
Professional Translation Team for Guaranteed Quality

Information Security and Confidentiality Mechanism

Oracle Translation fully understands the importance of information security. Throughout our cooperation, we implement rigorous processes and strict confidentiality measures to safeguard the security and privacy of your content across the entire project lifecycle. We hereby state that any product content, technical patents, documents, drawings, equipment manuals, and other materials involved in the translation services we provide are the intellectual property of the client, and the client retains the copyright to the translated documents. We must not disclose any content of the translation materials to any third party without authorization. In addition, we sign confidentiality agreements with both our clients and all employees, and enforce a strict internal confidentiality system. We have established tiered confidentiality plans and security measures, including network-isolated monitoring and secure USB drives. From the very beginning of the workflow, dedicated personnel are assigned to each stage to prevent any form of information compromise or leakage.

Name AM-Wang Age 46 Title Senior Reviewer
Main Qualifications and Project Experience:
Graduated from the Department of Microbiology at Fudan University, Shanghai, in July 1996;
English-to-Chinese translation of the technical manual for BD's "Single-Use Arteriovenous Indwelling Catheter Production Line" project;
Chinese-to-English translation of technical documents for "Critical Care Monitoring and the Application of Automated External Defibrillators (AEDs)";
Chinese-to-English translation of technical documents for the "China Hospital Management and Holistic Nursing Seminar";
English-to-Chinese translation of project documents for Baxter's "Baxter Fully Closed Infusion Bag" project;
Chinese-to-English translation of the technical manual for "The Application of Computer Integrated Systems in Medical Ventilators";
Chinese-to-English translation of documents for the "China Hospital Management System (HAS) and Computerized Automatic Logistics Conveyance System";
English-to-Chinese translation of FDA project documents on food safety, food poisoning detection, and emergency response;
English-to-Chinese translation of operational procedure documents for U.S. FDA Investigational New Drug (IND) review
Year of Service Major Projects Participated In Remarks
2014-2017 Translation of specialized documents for the joint meeting between the State Food and Drug Administration, the U.S. FDA, and the European Medicines Agency; translation of technical materials for the operational procedures of U.S. FDA Investigational New Drug (IND) review, etc. Recognized by the relevant departments of the State Food and Drug Administration and the FDA
Address: 21F, Building 19, Zhonghaixin Innovation
Industrial City, Jihua Subdistrict, Longgang District, Shenzhen
Phone: 400-680-7218
  • Translation Consulting

  • Translation Consulting

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