Quality Systems

Quality Compliance

We use the highest standards of EMA, US FDA, China FDA, Taiwan FDA, PMDA, Health Canada, ICH and PIC/s

  • World-class quality system built by industry veterans
  • Quality team leadership has deep industry experience from leading firms
  • Facility passed EU QP audits and obtained GMP license post TFDA inspection
  • Modern quality management tools including TrackWise, Facility Monitoring System (“FMS”) and an electronic Document Management Program
  • Implementing a Laboratory Information Management System (“LIMS”)
TFDA cGMP Compliance CertificateTFDA cGMP Compliance Certificate

Quality Control

The treatment of millions of patients around the world will depend on the safe and reliable production of biopharmaceutical medicines. Commitment, skill and experience is vital to help ensure the quality, from the first cell line cloning step to each time a new batch is released. At Eden Biologics, robust quality control and a reliable supply of medicines to our partners are the cornerstone of our business.

Compliance to International Standard

Eden Biologics is developing and manufacturing its biosimilar products under the highest standards in the industry. Our facility is designed and built to meet US FDA and Europe EMA standards. Single use technology is used to eliminate risks of cross contamination in fermentation and ensure high quality products.

Contact us to learn more!