WASHINGTON, DC, February 10, 2020: Morgan Lewis has added partner Dennis Gucciardo, a lawyer who counsels domestic and global medical device manufacturers on compliance with US Food and Drug Administration (FDA) regulations, requirements, inspections, and enforcement matters. He also assists in the defense of criminal investigations and conducts internal investigations of alleged regulatory violations. Dennis, who is resident in Washington, DC, arrives from another global law firm.
“Our global FDA practice serves medtech companies around the world that face increased challenges from changing regulations impacted by evolving technology,” said Firm Chair Jami McKeon. “Dennis has built a career advising these companies on how to bring novel technologies to market and how to address FDA warning letters, international inspections, and global recalls that disrupt product distribution and supply.”
Dennis, a frequent speaker on regulatory compliance and enforcement issues in the medtech industry, also works with device companies in conducting regulatory due diligence and negotiating corporate mergers and acquisitions. He has been involved in numerous transactions ranging from multibillion-dollar acquisitions to the negotiation of supply and distribution agreements.
“Dennis shares our firm’s commitment to exceptional client service and the central importance of our client relationships,” said Kathleen Sanzo, leader of Morgan Lewis’s FDA practice. “Regardless of the size or scope of the matter, he offers life sciences and healthcare companies broad medical device experience, in particular a strong background in post-approval FDA enforcement matters as well as corporate transactions.”