Our Services Customer

Customer Company Name

  • EirGenix, Inc. 台康生技
  • Orient PHARMA Co., Ltd. 友霖生技醫藥股份有限公司
  • Alvogen Lotus 美時製藥
  • PharmaEssentia Corporation. 藥華醫藥股份有限公司
  • Shining Biotechnology Co., Ltd. 尚寧生物科技股份有限公司
  • ScinoPharm Taiwan, Ltd.台灣神隆股份有限公司
  • National Tsing Hua University 國立清華大學 | 原子科學技術發展中心
  • Formosa Laboratories, Inc. 台耀化學股份有限公司
  • Intech Biopharm Co., Ltd 益得生技股份有限公司

Customer Company Name

  • Pfizer Inc.  輝瑞
  • Amgen Inc. 安進

Customer Company Name

  • Pfizer Inc. (China Hangzhou)  輝瑞杭州
  • Yangtze River Pharmaceutical Group 揚子江藥業集團
  • Livzon Group. 麗珠醫藥集團
  • Huadong Medicine Co.,Ltd 杭州中美華東製藥有限公司 
  • BeiGene Ltd. 百济神州有限公司
  • LivaNova PLC (China Suzhou) 理諾琺蘇州
  • Novartis Vaccines (China Hangzhou) 諾華杭州
  • CSTONE PHARMACEUTICALS 基石藥業
  • Suzhou Wanox Technology Co. Ltd 蘇州瓦諾

Our Services Project

  • Pfizer (USA Rocky Mount, NC)

    Drug Substance Buildings Line Expansion

    • Validation Protocol Development
    • SOP Development
    • Validation Protocol Execution

  • Pfizer (USA Sanford, NC)

    Drug Product Building Expansion

    • Validation Protocol Development
    • SOP Development
    • Validation Protocol Execution

  • Amgen (USA Rhode Island)

    Drug Substance Building

    • Owner’s Representative
    • Modular building
  • Eirgenix (Taiwan Hsinchu)
    • Validation Documentation Development
    • Environmental Monitoring System
  • Orient PHARMA (Taiwan Huwei)

    Filling/Finish Facility

    • Filling Equipment Project Manager
    • Validation Document Execution
    • Microbiological Laboratory Set up

  • Alvogen Lotus (Taiwan Nantou)

    Validation Documentation generation and execution for the following projects

     

    • Operational Efficiency Enhancement
    • Containment Project
    • Environmental Monitoring Project
    • Calibration and Maintenance Management Project

  • PharmaEssentia (Taiwan Taichung)

    Bulk & Fill/Finish Facility

    • Computer System Validation Project
  • Shining Biotechnology (Taiwan Taipei )

    Cell Preparation Facility Good Tissue Practice

    •  Validation Protocol Development
    • SOP Development
    • Validation Protocol Execution

  • BeiGene Ltd (China Guangzhou )

    Phase-II Drug Substance Downstream Equipment C&Q

    • Interface with international vendor for project management
    • Purification systems (Chromatography, Viral Filtration,TFF - Tangential Flow Filtration and  Bulk Fill Distribution) Commissioning and Qualification
    • Equipment change and instrument calibration management
    • Recipe development and GMP production support
  • CSTONE PHARMACEUTICALS (China Suzhou)

    Greenfield Automation Design Project

    • Automation Validation Master Plan generation
    • IT network requirements generation, conceptual design and budget estimation
    • EMS URS and design deliverables generation

  • Pfizer (China Hangzhou)

    Monoclonal Antibody Project

    • Computer system validation and risk assessments SOPs generation
    • Computer system validation protocol review as representative
    • Process control system local area network qualification
    • Validation execution for Delta V controlled new production areas 
    • Recipe development and water run support


  • Novartis Vaccines (China Hangzhou)

    Vaccine Facility Renovation Project

    • Design review, Commissioning and qualification management
    • DS and DP equipment URS generation for bidding and technical clarification
    • Vendor visit, selection and qualification

  • LivaNova PLC (China Suzhou)

    Medical Device Greenfield Project

    • SCADA system structure conceptual design and budget estimation
    • URS, validation plan and risk assessment generation

  • Yangtze River Pharmaceutical Group (China Taizhou)

    CSV (Computer Systems Validation)

    • SRM(Supplier relationship Management) System CSV activities management and execution
    • HCI (Hyper converged Infrastructure) and Cloud Desktop CSV activities management and execution

  • Livzon Group (China Zhuhai)

    Product Life Cycle Project

    • PLM System CSV activities management and execution
  • Huadong Medicine Co.,Ltd (China Hangzhou)

    Fill Finished Facility

    • Conceptual Design Project
    • Basic Design Project
  • Wanox Technology Co., Ltd (China Suzhou)

    ISO13485 Compliance Project

    • SOP generation for CSV and risk assessment
    • Site CSV validation master plan setup
    • ERP system CSV activities management and execution
  • Amgen (China Shanghai)

    Modular Faility Project

    • Modular facility design review and project execution management
    • Construction oversight on vendor site and SAT coordination
    • TOP deliverables review and punchlist follow-up