GMP Consulting & Compliance Improvement
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
