“Shep” has over 30+ years of experience working in the medical industry. He is an established thought leader and invaluable resource as a regulatory affairs professional whose goals are to enable global access to safe and effective biomedical technology and to facilitate technologies that improve the quality of life. He has spent the past 15 years as a full service biomedical regulatory consultant.
Since the establishment of his independent biomedical regulatory consultancy, Shep has been working closely with both large companies (Fortune 500) and small ventures around the world to facilitate their interaction with the FDA and has drafted submissions applying various novel approaches to the portrayal of drug and device risks to users, patients and clinicians. These submissions have produced competitive results for the companies that have engaged him, and he has been made the CEO on two occasions. He speaks at symposia and conferences including the FDA Annual Meeting (Orange County Regulatory Affairs) and various biotech events around the world (Europe and Asia), as well as throughout the U.S. He is a consulting COO for various Southern California biotech ventures, attends the Drug Information Association meetings and speaks at Parenteral Drug Association events. He works with drug discovery, development, and distribution, performing FDA pre-audits, and completing submissions. He is retained by various laboratories for essential compliance and is currently involved with several COVID-19 related initiatives.
Shep is an active member of the American Society for Quality - Biomedical Special Interest Group (ASQ), Regulatory Affairs Professional Society (RAPS), and The Organisation for Professional Regulatory Affairs (TOPRA). He maintains the Regulatory Affairs Certification for U.S. medical regulation.