Our Advantage:

• With lot of successful cases in compliance project (FDA, EMA/EDQM, WHO, ANVISA, PIC/S, and NMPA).

• Extensive experiences in the manufacturing of API, drug product and medical devices.

• With successful experiences to help China factory to pass FDA inspection.

• Having joint expert team from global companies and some experts are former FDA inspector.

• Global Third Party Auditing experiences (GMP/GLP/GCP/GEP/GSP)

   

  Services:

• Establish and upgrade the quality system

• Compliance improvement projects

• Help to respond to FDA 483

• Inspection support

• Compliance assessment

• Mock audit

• Third party audit

• Training

• Writing SOPs

• Risk management

• GDP / GMP / GLP / GCP /GEP consulting