Main Achievements

  • We have completed the following main development services so far.
  • Partial change of approval application on antibody pharmaceutical manufacturing method in Japan, taking request from Global Biopharma

  • Manufacture and sale approval of genentically engineered pharmaceuticals in Japan, taking request from Global Biopharma

  • Clinical pharmacology (PD/PK) to get regulatory approval in Japan, taking request from Global Biopharma

  • Technical training on injection manufacturing in Japan, taking request from Global Pharma

  • Training on GVP, GPSP (Good Post-marketing Study Practice) and Role Play of Handing SAE Information in Japan, taking request from Global Pharma

  • Obtaing the license of marketing authorization holder for first-class production and sales from Tokyo Metropolitan in Japan, taking request from England pharmaceutical company, etc.