Quality Management System：ISO13485，TUV-SUD; CE TUV-SUD; CE

Cleanrooms environment monitoring: fully compliant with the regulation and GMP requirements: including airborne particulate, microbe, air change times, pressure difference ,  flow speed, temperature., relative humidity and so on.

Process validation change management：Special process must be validated before manufacturing; Process change must be validated.

Laboratory: 2 Physical test rooms, 2 Chemical test rooms, 3 Biology test rooms, Gas Chromatograph, Audit Tracing Software.