

Jennifer Bonanno advises clients on effective strategies for bringing food additives, food-contact materials, medical devices, and pharmaceuticals to the marketplace in the United States, Europe, and Japan. In addition to her years of law firm practice, Jennifer’s prior experience as an in-house counsel informs her ability to understand the types of practical advice clients need to navigate the complexities of domestic and international regulations. Her background in chemistry also helps her to devise integrated scientific and regulatory strategies to assist clients with implementing marketing strategies or problem solving when issues arise.
Jennifer assists clients with FDA submissions, including food contact notifications (FCNs), threshold of regulation (TOR) requests, premarket notifications for medical devices (510(k) notices), and investigational new drug applications (NDAs). She also prepares legal opinion letters regarding the status of food additives, food-contact materials, drug packaging, and modified medical devices marketed under a 510(k) notification.
Before rejoining Keller and Heckman, Jennifer worked as general counsel at a semiconductor manufacturer and as FDA Counsel and Director of Regulatory Compliance for a small, biotech pharmaceutical company. She then worked for many years volunteering as a disability advocate.