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.
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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.
Memberships
American Health Law Association (AHLA)
American Bar Association
Domestic Violence Legal Empowerment and Appeals Project (DV LEAP) — Board Member (2014-2022)
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.
Memberships
American Health Law Association (AHLA)
American Bar Association
Domestic Violence Legal Empowerment and Appeals Project (DV LEAP) — Board Member (2014-2022)
Additional Experience
Life Sciences
- Represented investment firm affiliates in the successful sale of therapeutics company for $300 million in the aggregate of cash and stock, plus contingent consideration.
- Represented a holding company in its pending $193.5 million sale of a provider of vitamins and nutritional supplements.
- Represented multiple financial institutions as placement agents in connection with the $260 million PIPE financing commitment for a SPAC sponsored by affiliates of an investment firm, to combine with a clinical-stage biopharmaceutical company advancing novel small-molecule therapeutics.
- Represented a private equity firm in its acquisition of a provider of generic oral liquid medicines.
- Represented a therapeutics company in the up to $2.5 billion pending sale of a treatment program for breast cancers in clinical trials to a pharmaceutical company.
- Represented a private equity firm-backed healthcare services company in its pending acquisition of the unit-dose packaging business of a publicly traded global healthcare company.
- Represented a medical device company in the sale of its respiratory diagnostic business unit to another medical device company.
- Represented a pharmaceutical company in its $3.2 billion acquisition of a biotechnology company.
- Represented a global provider of mission-critical flow creation and industrial solutions in the $2.325 billion acquisition of a manufacturer for the pharmaceutical industry from an investment firm.
- Represented a pharmaceutical company in its $520 million acquisition of a provider of protein-based animal health therapeutics.
- Represented a private equity-backed company specializing in clinical research services in its $115 million acquisition of a provider of imaging biomarker services.
- Represented an animal health company in its $350 million acquisition of medicated feed additive and water-soluble product portfolios from a global animal health company.
- Represented a private equity firm in its $700 million acquisition of a medical device components business from a sustainable technologies and specialty chemicals company.
- Represented a diversified manufacturing company in the sale of its business unit specializing in interconnect technologies for various industries, including aerospace, defense, and medical, to a publicly traded global provider of interconnect and sensor solutions.
- Represented a pharmaceutical company in its $8.7 billion acquisition of a neuroscience drug company.
- Represented a private equity firm in its acquisition of a platform for pharma commercialization and market access.
- Represented a provider of generic and specialty pharmaceutical products in its sale to a pharmaceutical company.
- Represented a pharmaceutical company in its $1.4 billion acquisition of a radiopharmaceutical company.
- Represented a private equity firm in its investment in a clinical research site platform serving pharmaceutical and biotechnology companies and contract research organizations.
- Represented a private equity firm in its investment in a provider of strategic services across the entire life sciences product cycle.
- Represented a private equity firm in its pending $627 million acquisition of a provider of medical device and in vitro diagnostic technologies.
- Represented a private equity firm in its acquisition of a contract development and manufacturing organization of branded over-the-counter products.
- Represented a private equity firm in the recapitalization of a contract development manufacturing organization (CDMO) of non-sterile liquid and semi-solid dosage forms.
Healthcare Technology
- Represented a private investment firm in its investment in a provider of vascular access and medication management products.
- Represented a private equity firm in its acquisition of a provider of a consumer health & wellness platform for orthotics and other footcare-focused solutions.
- Represented a healthcare technology company in its acquisition of a provider of language interpretation services.
- Represented a healthcare technology company on the proposed $180 million acquisition of a leading provider of tech-enabled, healthcare-focused language interpretation services.
- Represented a private equity firm in its $680 million acquisition of a provider of health and wellness solutions.
Food & Beverage
- Represented a private equity firm in its acquisition of a hot sauce brand.
- Represented a private equity firm in its acquisition of a provider of bakery products for quick service restaurants and in-store retail bakeries.
- Represented a private equity-backed pet wellness company in its sale of a production facility in Indiana to a pet food producer.
- Represented an investment firm in its acquisition of a provider of pet supplements.
- Represented a private equity firm in its acquisition of a provider of sparkling water, teas and lemonades, hard seltzers and mocktails.
- Represented a middle-market private equity firm in the sale of a provider of disposable food safety and hygiene-oriented products for the foodservice industry.
- Represented a private equity firm in its investment in a brand of premium condiments and truffle-infused products.
- Represented a private equity firm in its pending EUR 16 billion acquisition of a provider of over-the-counter drugs and vitamins, minerals and supplements.
- Represented a New York-based private equity firm in its acquisition of a super fruit bowl franchise restaurant.
Additional News & Insights
Publications
- “Navigating FDA Risks in Life Sciences M&A: A Practical Diligence Guide,” American Health Law Association (May 28, 2026)
- “From the Locked Medicine Cabinet to Locker Rooms: The Sports Playbook for Medication Compliance; Assessing the Risks and Realities” (co-author), Sports Litigation Alert, Volume 23, Issue 2 (January 22, 2026)
- “Beyond borders 2025: the top five considerations on the road to success in cross-border life sciences M&A” (co-author), International Bar Association (December 18, 2025)
- “Heading For An M&A? Understand The Risks And Mitigation Strategies For Clinical Trial Agreements,” Clinical Leader (November 10, 2025)
- “Recent Listeria Outbreaks Hold Key Compliance Lessons” (co-author), Law360 (November 21, 2024)
Presentations
- “Regulatory Enforcement: What Advertisers and Agencies Need to Know,” ANA Advertising Law 3-Day Conference (April 23, 2026)
- “Beyond the Fine Print: Liability, Indemnification, and M&A Risks in Clinical Trial Agreements,” Northeastern University’s ALERT Program (January 29, 2026)
- “Navigate the Intricacies of Company Mergers and Their Impact on CTAs,” 6th Annual Clinical Trial Agreement Conference (August 21-22, 2025)
Media Mention
- “FDA’s PreCheck: pharma industry calls for clarity in 30 Sep public meeting,” Lexology Pro (October 1, 2025)
Accolades
Kayo Conference Series — Top 26 in ’26: Women on the Move in Healthcare (2026)
American Lawyer Media — Most Effective Deal-Maker (2023)
The M&A Advisor — Healthcare/Life Sciences Deal of the Year (2022)
North Carolina Lawyers Weekly — Leaders in the Law (2020)
National Law Journal — Cannabis Law Trailblazer (2020)
Accolades
Kayo Conference Series — Top 26 in ’26: Women on the Move in Healthcare (2026)
American Lawyer Media — Most Effective Deal-Maker (2023)
The M&A Advisor — Healthcare/Life Sciences Deal of the Year (2022)
North Carolina Lawyers Weekly — Leaders in the Law (2020)
National Law Journal — Cannabis Law Trailblazer (2020)
