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hello and welcome to the second of three on-demand webinars titled from discovery to development choosing the right contract service provider brought to you by thermo fisher scientific and in partnership with the university of california san diego extension program my name is casey kyne senior manager of regulatory affairs clinical and compliance here at thermo fisher scientific and im delighted to be joined by two experts today to help shed light on integrating cgmp from clinical trials to commercialization first id like to introduce professor ajit sim ajit established shiba biotechnology in 1999 to provide regulatory compliance quality strategy and support to the biotech pharmaceutical and medical device industry ajit has worked with several multinational pharmaceutical companies and products over his 30 years in industry ajit has successfully hosted fda and ema inspections and conducted several pre-approval inspections which led to successful outcomes he is a member of pda and is