K A Ajit-Simh
M.S.

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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.

Ajit-Simh, K A

My Courses

Good Laboratory Practices
By addressing fundamental regulatory compliance principles relative to the FDA's current Good Laboratory Practice regulations, this course will show how GLP's affect the conduct of non-clinical...
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Regulatory Compliance for Drugs & Biologics
Regulatory Compliance is the level of activity that provides assurance to the sponsor and the regulatory agency that all phases of drug development are conducted in compliance to the good practice...
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