Canton Biologics strictly conducts qualification and validation at various stages of drug development life cycle (e.g. from raw materials to drug products (DP) and from clinical sample manufacturing to commercialmanufacturing). Strictly following internal QA instructions and domestic and global regulations, our QC team develop and validate QC assays to set up QC and DS/DP release standards to ensure all DS/DP released meet that standard.
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>20 years of experiences in both clinical and commercial batch manufacturing
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Familiar with local and global QA regulations (USFDA, ICH, PIC/S, EDQM, MHRA, PDA, ISPE, EMA, WHO)
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Rich experiences in preparing regulatory submission package
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Strong assay development