Steve is the founder and President of C³ and Regulatory Affairs Associates [RAA] – a worldwide leader in getting medical devices and drugs approved by FDA and in other countries.
A forensic toxicologist and lawyer, Steve has more than 40 years experience as a regulatory professional. Steve began his career at the Chief Medical Examiner’s Office in New York, developing the first reliable drug screening tests for many drugs, and launching the Drug Screening industry. He then developed the drug methadone, getting FDA approval and managing that start-up company.
He is noted for his professionalism, knowledge and ability to navigate successfully in the complex regulatory world of medical device and drug approval. And his business sense frequently allows clients to realize hidden opportunities in this highly regulated work environment.