ALEX SMITH is the senior director of regulatory compliance in the firm’s Washington, D.C. office. Alex focuses on counseling clients regarding the development and regulation of medical devices, pharmaceuticals, and combination products. Prior to Sidley, Alex worked for several major combination product pharmaceutical manufacturers with varying roles in process engineering, manufacturing automation, software development and laboratory quality control.
Alex’s FDA practice group is actively involved with pharmaceutical and medical device manufacturers around the globe to provide assistance on a wide variety of projects. On a yearly basis, Alex has supported more than 100 medical device 510(k), DeNovo, and PMA submissions. In particular, Alex has submitted over 50 DeNovo, 510(k), and IND submissions involving AI/Machine Learning, given his background as a software engineer.
In addition to FDA medical device and drug submissions, Alex spends a considerable amount of time performing international investigations resulting from data integrity lapses, consent decrees, FDA 483s, warning letters, and deferred prosecution agreements.
**Not Admitted to Practice Law**