Quality and Compliance
As an CRDMO for global pharmaceutical companies, Lianhe Aigen have established an end to end quality management system based on international GxP regulations & guidelines to ensure patient safety and product quality, covering drug discovery and development, pre-clinical, clinical, and final commercial manufacturing.
Our facilities have been successfully inspected and approved by regulatory authorities such as FDA, NMPA, EMA, PMDA, TGA, KFDA, etc., as the proven track record for us to deliver our commitments to customers on time in full with quality. Lianhe Aigen are approved and commercially delivered APIs to more than 100 countries/markets, and served millions of patients around the world together with our customers.
Inspection History by Key Global Health Authorities
GMP QMS
A comprehensive quality management system with FDA recommended 6 GMP elements，is established based on the concept of "quality by design" to drive the continuous improvement, then enhance patient safety and product quality.
-End to end quality management system to cover the whole product lifecycle
-Experienced quality professionals to ensure GMP compliant
-Comprehensive oversight system to ensure data integrity
-Dedicated intelligence monitoring team to catch up latest regulation requirements and best industry practices
Production System
Quality System
Packaging Labeling System
Material System
Facilities Equipment Systems
Laboratory Control System
GMP
GMP Certificates
Successfully passed the onsite inspections from the global key health authorities, such as NMPA, US FDA，EMA, TGA, PMDA, etc. and currently supply commercial APIs to more than 88 countries/areas. The submission and approval in other countries/areas are on-going.
2023 FDA EIR Cover Page General
2023 PMDA GMP certificate
2023 Written Confirmation for active substances exported to EU (Remibrutinib)
2022 Written confirmation for active substances exported to EU
2022 TGA GMP Certificate- Authorised 10 May 2023
2022 Korean Site registration notification
2021 Written confirmation for active substances exported to EU
2020 NMPA
2019 GMP-Certificate （EMA）(jiangkou）
Partnering With Us
Many years of CRO/CDMO experience and excellence solutions in certified quality management and advanced technologies ensure us as your trusted partner.
What Can We Help You?
We provide customers with one-stop CRDMO services covering the entire lifecycle of drugs.
