Sonali Gunawardhana is Counsel at the law firm of Shook, Hardy & Bacon L.L.P. in Washington, DC. She draws on her nearly 10 years’ experience as an attorney at FDA to offer clients detailed and practical guidance on how to avoid and resolve FDA regulatory challenges. Ms. Gunawardhana’s practice focuses on the rapidly changing FDA regulatory requirements for bringing pharmaceuticals and medical devices to market; the complex emerging rules applicable to domestic and foreign food manufacturers, suppliers, and importers; clinical trial compliance requirements for drug and medical device studies; and the defense of FDA enforcement actions against drug, device, food and dietary supplement companies, Clinical Research Organizations (CROs), academic medical research institutions and individual researchers. Ms. Gunawardhana received a BA from Syracuse University, a MA from Webster University, a MPH from Boston University, a JD from the University of New Hampshire School of Law and a LL.M. from Washington College of Law, American University.