Quality Management

Seasoned and Stable Quality Management System

  • China

  • Brazil

  • Ukraine

  • Columbia

  • Mexico

Core competencies:

Following ICH Q10 and FDA‘s ICH Q9 to design, enhance and maintanance a robust and systematic QMS;

Knowledge management and quality risk management approach to drive continuous improvement and support;

Inspection by cFDA and other national health agencies from Europe, North/South America, and etc.

Regulatory History

Regulatory Track Record of Recent 5 years
  • Country/Client

    Date

  • EU Client

    2017.10

  • Columbia

    2017.07

  • Mexico

    2017.07

  • cFDA

    2017.03

  • cFDA

    2016.09

  • Columbia

    2014.07

  • cFDA

    2013.11

  • Ukraine

    2013.01

  • Brazil

    2012.09

Successfully completed all regulatory inspections including 14+ spot checks;

Successfully completed GMP certifications from multiple countries including cFDA, Brazil, Mexico, Ukraine;

Successfully completed multiple client inspections (domestic/international).

Note:The map highlights the earliest approved years.