Leading FDA Expert
Brought more than 40 Class II and Class III devices from R&D through clinical trials, manufacturing, to FDA-approval.
Developing quality systems and preparing regulatory submission.
Wrote 50 successful submissions to CDRH and CBER of the FDA.
BS in microbiology: University of South Florida.
PhD in virology/molecular biology at Virginia Tech, Postdoctoral Fellow in Biochemistry Harvard.