Kate Hardey advises healthcare and life sciences companies, investors, and lenders on regulatory matters and complex transactions, with a focus on Food and Drug Administration (FDA)‑regulated products and private equity investments across the healthcare industry. Her experience includes matters ranging from middle-market transactions to multibillion-dollar deals involving complex FDA-regulated and healthcare-adjacent businesses. Kate is known for her ability to integrate FDA, healthcare regulatory, transactional, and operational considerations, drawing on extensive industry experience as in-house legal counsel within a large hospital system, and physician practice manager. She also advises professional sports teams and related stakeholders on player medication and healthcare matters, including team and player medication management and facility and equipment licensing compliance.
Kate frequently speaks and writes on healthcare regulatory developments and transaction-related risk, particularly in the life sciences and FDA-regulated industries. She has been quoted in media outlets such as The Wall Street Journal and has served as a guest lecturer for Northeastern University’s ALERT Program, where she presented on liability, indemnification, and M&A risks in clinical trial agreements.
Kate Hardey advises healthcare and life sciences companies, investors, and lenders on regulatory matters and complex transactions, with a focus on Food and Drug Administration (FDA)‑regulated products and private equity investments across the healthcare industry. Her experience includes matters ranging from middle-market transactions to multibillion-dollar deals involving complex FDA-regulated and healthcare-adjacent businesses. Kate is known for her ability to integrate FDA, healthcare regulatory, transactional, and operational considerations, drawing on extensive industry experience as in-house legal counsel within a large hospital system and physician practice manager. She also advises professional sports teams and related stakeholders on player medication and healthcare matters, including team and player medication management and facility and equipment licensing compliance.
Kate frequently speaks and writes on healthcare regulatory developments and transaction-related risk, particularly in the life sciences and FDA-regulated industries. She has been quoted in media outlets such as The Wall Street Journal and has served as a guest lecturer for Northeastern University’s ALERT Program, where she presented on liability, indemnification, and M&A risks in clinical trial agreements.
Kate’s practice is concentrated on:
- FDA & Life Sciences – Counseling pharmaceutical, biotechnology, medical device, digital health, diagnostics, laboratory, animal health, dietary supplement, food, beverage, cosmetic, and consumer product companies on FDA regulatory requirements across the full product lifecycle, including development, clinical trials, product classification, manufacturing, quality systems, labeling and promotion, commercialization, post-market compliance, enforcement risk, and recalls, in addition to supporting life sciences companies in structuring and executing strategic transactions involving FDA-regulated assets.
- Healthcare Regulatory – Providing guidance on complex healthcare regulatory frameworks and compliance structures, including fraud and abuse laws such as the Anti-Kickback Statute and Stark Law, with an emphasis on how those rules intersect with FDA-regulated products, reimbursement, commercialization models, and healthcare operations. She advises pharmacies, pharmacy-adjacent businesses, and investors on the regulatory and operational requirements that shape dispensing, distributing, licensing, contracting, and broader pharmacy business models. She also counsels on corporate practice of medicine considerations and operational regulatory risk across healthcare delivery platforms, including businesses that combine provider, pharmacy, laboratory, and product-related functions.
- Private Equity & Healthcare Transactions – Representing private equity sponsors, strategic acquirers, and lenders in acquisitions, divestitures, and investments across the healthcare and life sciences sectors. She advises on regulatory diligence, structuring considerations, and risk mitigation in transactions involving life sciences companies, providers, healthcare services platforms, and consumer health sectors.
In addition to her healthcare and life sciences work, Kate advises companies and investors in the food and beverage sector. She represents private equity firms and strategic clients in transactions involving food, beverage, dietary supplement, and other consumer product businesses and counsels on regulatory considerations affecting food products, including those subject to FDA and USDA oversight. Her experience spans a range of subsectors, including packaged food, beverages, dietary supplements, pet food, and food safety–focused products, allowing her to guide clients through both transactional and regulatory complexities unique to the industry.
