Bethany leverages her deep FDA regulatory experience and exceptional knowledge of the healthcare delivery system to help both domestic and international life sciences and healthcare technology clients enter and navigate the U.S. market. She helps companies manage the full range of FDA regulation issues, from inspections and investigations through complex regulatory challenges, affecting everything from product approvals and labeling to collaborative research, supply, and distribution agreements. Her work for clients regularly spans the full scope of pre-market and post-market issues, devising unique regulatory strategies that are then implemented through FDA submissions, including post-approval compliance and enforcement.
Bethany advises her life sciences business clients on both pre- and post-market issues, including everything from FDA submissions and communications strategies to post-approval compliance and reimbursement issues. Her clients include medical device, drug, combination product, diagnostic, biologic, and regenerative medicine, cosmetic, dietary supplement, and food industry companies, and the investor groups focusing on these industries.
When the theme of our inaugural event was “Disrupt or Be Disrupted” little did we know that a pandemic was on the horizon. This panel is going to take an indepth look at just how COVID changed Telehealth, accelerated its implementation and what the landscape looks like now. A discussion will begin by defining telehealth […]