“ I’m passionate about the innovative technologies and services my clients offer, and I bring a practical, full life cycle approach to my counsel that includes not just core FDA regulatory compliance, but also a deep understanding of product reimbursement and the healthcare systems the products will be used in.
Bethany J. Hills advises her life sciences and health tech industry clients on both pre- and post-market issues, including everything from FDA submissions and communication strategies to post-approval FDA and healthcare compliance and reimbursement issues. Her clients span the full range of FDA and healthcare regulated companies, including medical device and health tech, drug, combination product, diagnostic, biologic, and regenerative medicine, cosmetic, dietary supplement, and food industry businesses, and the investor groups focusing on innovation in these industries.
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 product development and classification, to 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, from devising unique regulatory strategies that are then implemented through FDA submissions, including post-approval FDA and healthcare compliance and enforcement.
Through her extensive representation of healthcare technology and virtual care businesses, she has an understanding of healthcare compliance issues that far surpasses most other FDA lawyers and is invaluable to the success of product launch and sustainable growth. Bethany uses her strengths in these areas to advise clients on regulations applying to referral relationships, clinical trial compliance, licensure, and security and privacy issues, as well as the intricacies of government and third-party reimbursement. Clients rely on Bethany’s practical guidance to help them invest and collaborate strategically by identifying technologies that are likely to complement the healthcare delivery system, clear FDA regulatory hurdles, and realize commercial success.
Bethany works globally with academic centers to educate future business leaders on relevant regulatory issues and is a frequent author and speaker on topics concerning FDA regulations, healthcare reimbursement, and life sciences compliance. She is also an angel investor in life sciences and health tech companies.Show More