K.A. Ajit-Simh established Shiba Biotechnology Inc., in 1999 to provide regulatory compliance, quality strategy and support to the biotechnology, pharmaceutical and medical device industry. Ajit has worked with several multi-national pharmaceutical companies and products over his 30+ years in this industry. Ajit has successfully hosted U.S. FDA and EMA inspections and conducted several mock pre-approval inspections (PAI) which led to successful outcomes. He is a member of PDA and is an adjunct professor and instructor at SDSU in regulatory affairs.