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.
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)