FDA lawyer working in industry for hundreds of medical device and biotech companies, with deep science experience as forensic toxicologist. I've invented and launched drug and lab testing products and companies. Currently starting 4th company, cureLauncher.com to bring bridge funding to start up NIH caliber medical science companies and accelerate clinical trials. My consult company, Regulatory Afffairs Associates is the FDA advisor to National Institutes of Health. I've gotten over 200 medical devices approved in USA and ROW, and a dozen drugs.