Journey to Global STD

About Us > Journey to Global STD

The history of BioInfra is itinerary towards Global Standard.

Obtained domestic standard study certification -> Obtained international standard study certification -> Achieved certification for ISO: Management System -> Obtained global certification in automation
    • 2007.05 Foundation of BioInfra Co., Ltd.
    • 2009.01 Assigned as KGLP institution
    • 2009.02 Met requirements of bioequivalence study institution
    • 2009.04 Accredited as venture company
    • 2011.12 Received INNOBIZ certification
    • 2012.08 In conformity with WHO Pre-Qualification Audit
    • 2012.10 Assigned as bioequivalence study institution
    • 2012.10 In conformity with Pfizer, USA Audit
    • 2014.09 In conformity with Sanofi, Japan Audit
    • 2018.12 Accredited as KGCLP institution
    • 2020.01 Achieved certification for ISO: Management Systems
    • Information security management systems (ISO/IEC 27001)
    • Quality management systems (ISO 9001)
    • Environmental management systems (ISO 14001)
    • Anti-bribery management systems (ISO 37001)
    • Occupational health and safety management systems (ISO 45001)
    • 2023~ Received Computerized System GAMP (Good Automated Manufacturing Practice) certification
    • LIMS (Lab Information Management System)
    • Automated Workstation
    • Data Processing & Reporting System
    • DM Platform (CDISK, SEND)