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Mr. Xxxx Xxxx is Vice President of Regulatory Affairs at XxxxxxxxXxxxxx Xxxxxxxxxxxx, a pharmaceutical CDMO. Xxxxxxx has over 25 years experience in international regulatory affairs, CMC, Biologics, quality assurance, environmental monitoring due diligence, regulatory obligations for cloud computing, electronic data management systems (EDMS), US / International health agency registrations, site audits and research compliance. Xxx Xxxx also has experience in quality assurance audit support for the FDA/GMP manufacture of prescription drug products, including FDA submissions in support of New Drug Applications (NDAs). Xxxxxxx also serves as an advisor to various Fortune 100 global pharmaceutical manufacturers.
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