As Vice Chair of the firm’s FDA practice, Bethany Hills advises life sciences and health tech industry clients on complex pre- and post-market product and distribution issues. Her clients span the full range of FDA regulated companies, including medical device and digital health, drug, combination product, diagnostic and biologic, as well as regenerative medicine, cosmetic, dietary supplement and food industry businesses. She also represents investor groups that focus on innovation in these industries.

Bethany helps companies manage strategic and critical FDA regulation issues including product development and classification, governmental inspections and investigations, and complex regulatory challenges such as product approvals and labeling and collaborative research, supply and distribution agreements.

In addition, Bethany has deep expertise in healthcare delivery systems, referral relationships, clinical trial compliance, licensure and security and privacy issues, as well as the intricacies of government and third-party reimbursement. Bethany’s practical guidance helps clients invest and collaborate strategically by identifying technologies that are likely to thrive within the healthcare delivery system, clear FDA regulatory hurdles and realize long term commercial success.