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.
Bethany leverages her deep FDA regulatory experience and exceptional knowledge of the health care delivery system to help both domestic and international life sciences and health care 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.
Through her extensive representation of health care provider businesses, Bethany has an understanding of compliance issues that far surpasses most other FDA lawyers. She 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 health care delivery system, clear FDA regulatory hurdles, and realize commercial success.
Bethany works with academic centers to educate future business leaders on relevant regulatory issues and is a frequent author and speaker on topics concerning FDA regulations, health care reimbursement, and life sciences compliance. She is also an angel investor in life sciences companies.
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