客戶實績

項目功績

項目功績

Successfully participated & cleared Regulatory Audits, some of them are
在擔任 GMP 顧問期間,成功實施品質系統輔導,參與並通過了作為的法規審核,其中包括:

  • USFDA - Cosmetic API plant, Taiwan (Nov 2018)
  • TFDA – Drug API plant, Taiwan (Feb 2018).
  • USFDA – Chemical/API plant, Taiwan (2016/2018)
  • TFDA – Sterile Injectable plant, Taiwan (2017)
  • TFDA - Chemical/API plant, Taiwan (2016).
  • TFDA – Drug API plant, Taiwan (2016)
  • MHRA – OSD Plant, UK (2013/2014)
  • AEMPS/ANSM - Sterile Injectable plant, Taiwan (2012)
  • USFDA - Tablet/Capsule Plant, South Africa (2012)
  • USFDA – Soft gel / OSD Plant, India (2011)
  • MHRA / USFDA / KFDA / TFDA - Sterile API Plant, Taiwan (2010/2011)