Consultant Team

Our consultants are seasoned professionals with years of experience at small to large companies.   Small and medium sized companies benefit from integrating new best practices that scale as quickly and efficiently, as clinical programs scale. 

Mike Dubinsky, Consultant, served with the FDA for 24 years and with pharmaceutical companies for 8 years since leaving FDA. Mike received numerous commendations during his tenure at the FDA and was the Deputy Director, Office of Compliance, at CBER when he left the agency. During Mike’s time with industry he held executive level positions yet was always actively engaged in the day to day activities. Since late 2006 he has provided consult services for pharmaceutical and biotech firms in GXP compliance and quality with a focus on GCP.  (Mike Dubinsky Resume)