Canton Biologics strictly 城新conducts qualification and validatio還放n at various stages of drug develo他明pment life cycle (e.姐謝g. from raw materials to drug pro拿吃ducts (DP) and from clinical samp朋她le manufacturing to commercialma師吧nufacturing). Strictly西姐 following internal QA i票湖nstructions and domes街東tic and global regulations, our QC 裡熱team develop and validate QC a商自ssays to set up QC and DS/DP re西錯lease standards to ensure all DS喝行/DP released meet tha道東t standard.

>20 years of experienc放看es in both clinical and comme男爸rcial batch manufacturing

Familiar with local and glo來算bal QA regulations (USFDA, ICH, PI妹老C/S, EDQM, MHRA, PDA, ISPE雨姐, EMA, WHO)

Rich experiences in prepari文雜ng regulatory submission package 業有

Strong assay dev現上elopment