• Quality Control & EHS & IP Protection

Quality & Compliance

We have passed several regulatory authority inspections, including 6 inspections by China NMPA and 3 joint State and Provincial NMPA on-site PAI and GMP inspections for NDA by MAH. Additionally, we have passed over 220 client audits and 5 EU third-party QP GMP audits since 2021.

ChemExpress has established a strict quality management system, and has got ISO9001 certificate in 2012. The quality management system regulates all projects from starting-up to delivery.

  • 220+
    Clients’ Audits
  • 9
    Regulatory Authorities Inspections
2012
  • May
    Certified to ISO 9001:2008 Quality management systems
2015
  • Aug
    1st Sec DMF filled for GMP int. of Calcipotriol
2017
  • Oct
    GMP under construction
2019
  • Feb
    Certified to ISO 14001:2015 Environmental management systems
2020
  • Dec
    RSM supplier of 1st ADC drug in China
2022
  • Feb
    5th Sec DMF filed for RSM of ADC drug
  • May
    cGMP upgrading
2023
  • April
    Certified to ISO 45001:2018 Occupational health and safety management systems
  • Health
  • Environment
  • Safety

Environment, Health And Safety

Awareness of environment protection and employee safety has been effectively ensured by EHS department. Safety first has always been our code of conduct. we have established two laboratories for process chemistry safety assessment. The reaction safety data obtained from DSC and reaction calorimetry studies provide fundamental thermodynamic data to support process chemistry optimization, scaling-up, and process safety.

IP Protection

We implement IP management strictly to ensure the confidentiality of clients’ intellectual property and the safety of data, information transmission, and data storage.