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Quality

Quality & Regulatory

Our world-class quality systems, harmonized globally across all sites, include separate quality compliance, quality assurance, quality control, and regulatory affairs functions. The various sites’ quality systems have been approved over 35 times via inspections and audits by multiple global regulatory agencies including the U.S. FDA, EMA, NMPA, PMDA, MFDS, HSA, ANVISA and Health Canada for a variety of biologics.

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