Life Sciences and Health Care

Navigating complexities in the life sciences and health care industries is no easy task. Successfully competing in the space requires increasingly creative strategies and integrated solutions that protect and support your business day in and day out.

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Life Sciences and Health Care

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Our services
Testimonials
Contacts
Our experience
Recognitions
Insights

Regardless of the sector in which you operate or the maturity of your products, we understand how to bridge the gap between the challenges you face and the outcome you want. From budding startups to multinational enterprises, we've been there before and know how to position you for success.

With more than 500 life sciences and health care lawyers across the globe, we can work closely with you to tackle tough issues and difficult-to enter markets – no matter where you are today or want to be tomorrow.

And because we know what makes your industry tick, we have a deep understanding of the issues you face – helping you stay ahead of the curve and on top of your opportunities.

Whatever your challenge, wherever the issue, we have the lawyers to help you.

Cell, Tissue, and Gene Therapies

Clinical Trials

Artificial Intelligence (AI) and Digital Health

Emerging Companies and Investors

Licensing and Commercial Transactions

Medical Devices

Pharmaceuticals and Biotechnology

Hospitals and Health Care Providers

Health

We have significant experience guiding clients around the world that are at the forefront of stem cell, regenerative medicine, and advanced therapy innovations. Advising universities and companies, our experience spans research and development, licensing deals between inventors, manufacturing, complex regulatory and commercialization questions, reimbursement, distribution, and intellectual property (IP).

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Our clinical trials team helps clients bring new drugs, biotechnology products and medical devices to market. We provide specialized advice to companies big and small through their entire journey – from nascent proof-of-concept studies and process development to seeking regulatory approval and managing product lifecycles. With a cross-disciplinary approach, a deep talent bench, and our knowledge of and contacts within the United States (U.S.), European Union (EU), and Asian government agencies, we ensure a comprehensive, integrated and risk-based strategy for issues that arise in drug and device development.

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As the industry forges ahead to advance the digital health ecosystem, the companies in this space will navigate a complex set of business and legal issues that are often evolving in real time. Our cross-jurisdictional team of lawyers bring a real-world sensibility to your challenges and business opportunities. We take a technology-based approach to counseling on digital health products and services and provide strategic guidance on how to leverage opportunities for growth, minimize legal barriers, comply with rules, protect data, and realize its value.

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From corporate formation to patent protection and strategy to initial financing rounds, we can help your company lay a strong foundation. With life sciences and health care industry expertise at the forefront, we can help your business grow. As your needs evolve, our team of lawyers can support your company’s strategic business needs relative to your product’s development stage, including regulatory approval planning, clinical trial design, pricing and reimbursement strategy, licensing, collaborations and other commercial transactions, and commercialization and product launch planning. And when the time comes, we’re prepared to support you in exit planning and execution through initial public offering (IPO), mergers and acquisitions, or asset monetization through strategic collaborations and cross-border licensing.

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Our dedicated team of life sciences and health care licensing and commercial transactions lawyers understand the challenges and opportunities that strategic alliances and other partnering relationships present. We work extensively with pharmaceutical, bioscience, medical device, academic, and other research entities on licensing, collaboration, and commercial transactions involving products and technologies at all stages of the product lifecycle and the company’s development.

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Creating and commercializing a cutting-edge medical device is demanding work. Remaining compliant in the face of ever-increasing regulation makes that job even more difficult. We leverage the vast experience gleaned from guiding companies of all sizes through the hard-to-navigate health care environment. We ask the right questions and explore uncovered possibilities to put your product in the best position for success.

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Drug companies face pressure from many directions – from a challenging regulatory landscape, from competitors with alternative brands or generics, from insurers pushing back on prescription drug costs and reimbursement. Whether you're a global pharmaceuticals company or a biotechnology startup, we can help you accomplish your business goals, even in a highly regulated industry, by providing practical, integrated legal analysis and advice. At the same time, we can help you maximize the benefits of statutes that encourage new drug development.

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Changes in government policy, regulation and the market are transforming hospital operations and health care delivery. New challenges are constantly arising in an already demanding environment. We can help you effectively navigate today's regulatory environment and capitalize on strategic opportunities.

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We know how overwhelming it is to effectively navigate today's regulatory environment and capitalize on opportunities. Because we have an in-depth understanding of the relationship between government and the global health care marketplace, we can provide legal solutions that are aligned with your business strategy. We are especially well positioned to serve providers and suppliers of health care services and products, along with all other players in the health care sector. We work with them as regulatory lawyers, strategic advisers, lobbyists, litigators and dealmakers. From start-ups to multinational enterprises and trade associations, our clients come from every part of the global health care sector. We are particularly effective, because an exceptionally high number of our lawyers are former senior government officials. This means we have insight into institutional thinking and decision-making processes at regulatory agencies, enabling us to be more persuasive when encouraging regulators to take a certain view or course of action.

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Our capabilities at a glance

500

Over 500 life sciences and health care practitioners worldwide working together seamlessly.

A market-leading practice with over 22 Band/Tier 1 directory rankings globally.

1700

We work with the top biotech, pharmaceutical, health and devices companies globally.

Hear from our clients and industry leaders

Hogan Lovells are one of the best life sciences teams. They combine a depth of experience including the associates with an energy and working style that clients love, achieving great results.

Chambers Global

Hogan Lovells are able to jump into action on short notice and produce high-quality work within tight timelines.

Chambers Global

First and foremost is the breadth and depth of the team's actual experience on regulatory matters - it is unmatched by any other firm.

Chambers USA

Key contacts

Steve Abrams

Partner

Steve Abrams

Partner

Philadelphia

Lynn Mehler

Partner

Lynn Mehler

Partner

Washington, D.C.

Jane Summerfield

Partner

Jane Summerfield

Partner

London

Meet the Life Sciences and Health Care team

How we’ve helped our clients succeed

Guiding Orphalan’s U.S. market entry

Regulatory

Bringing rare disease innovation to life Guiding Orphalans US market entry

Guiding Orphalan’s U.S. market entry

Regulatory

Female scientist wearing protective eyewear interacting with a transparent digital screen displaying anatomical brain and body data, symbolizing innovation in healthcare AI — used for Hogan Lovells case study.

Advancing healthcare innovation in the U.S. with the AI Healthcare Coalition

AI Hub

Advancing healthcare innovation in the US with the AI Healthcare Coalition

Advancing healthcare innovation in the U.S. with the AI Healthcare Coalition

AI Hub

Representative experience

Pharmaceutical and biologics companies in connection with the numerous federal and state investigations of sales and marketing, pricing Medical rebate, Federal Food, Drug, and Cosmetic Act (FDCA) promotional issues, and Current Good Manufacturing Practice (cGMP) compliance.

MorphoSys on a global collaboration and license agreement with Incyte Corporation to further develop and commercialize tafasitamab, an anti-CD19 antibody currently in development to treat blood cancer.

IDx LLC to achieve De Novo reclassification from the FDA for the ground-breaking AI-based device IDx-DR, which autonomously analyzes images of the retina for signs of diabetic retinopathy.

Awards and recognitions

Band 1 for Life Sciences

Chambers Global: Multi-Jurisdictional

2025

Band 1 for Life Sciences Europe-wide

Chambers Europe

2025

Band 1 for Life Sciences in Japan

Chambers Asia-Pacific

2025

Band 1 for Healthcare: Pharmaceuticals/Medical Products - District of Columbia

Chambers USA

2025

Band 1 for Privacy & Data Security: Healthcare - Nationwide

Chambers USA

2025

Band 1 for Healthcare – District of Columbia

Chambers USA

2025

Band 1 for Life Sciences Regulatory/Compliance

Chamber USA

2025

Tier 1 for Life Sciences and Health Care: foreign firms

Legal 500 Greater China

2025

Tier 1 for Healthcare Life Sciences in Germany

Legal 500 EMEA

2025

Resources

Guide

Horizons 2025 Life Sciences and Health Care Edition

Our Horizons edition brings together insights from across our global Life Sciences and Health Care team, exploring the issues and developments shaping the future of the industry.

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Guide

Life Sciences and Health Care Resource Guide

This resource guide offers access to the latest tools, information, and insights designed to help your company stay ahead of the curve. From industry updates to thought leadership, it’s your go-to source for staying informed and prepared for what’s next.

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Our thinking

Talking the Cure Podcast

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover cutting-edge topics such as AI, digital health, diversity in clinical trials, supply chains, the Inflation Reduction Act, and more.

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Insights

M&A Year in Review

The life sciences and health care sectors are poised for strong M&A activity in 2025, driven by innovation, strategic acquisitions, and technology adoption. This is despite regulatory and economic challenges, with companies focusing on growth, risk mitigation, and portfolio optimization.

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Digital Client Solutions

AI Hub

As innovation surges, the AI landscape is rapidly evolving. Our interactive AI Hub serves as a central resource covering the latest trends and developments. Explore the hub to find our recent thought leadership, navigate new laws and regulations, and to get in touch with our AI market leaders.

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Insights

Geopolitical Uncertainty

Dramatic shifts in geopolitics and the increased use of national security measures by governments around the world are impacting global businesses in unprecedented ways. With uncertainty comes opportunity and our team can help you navigate these challenges to create resilience for your business.

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Our thinking

The False Claims Act Guide

In the latest edition of our False Claims Act Guide: 2024 and the road ahead, we analyzed the key developments from 2024 and discuss how the most important cases and issues are shaping enforcement now and in the year to come.

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Insights

Inflation Reduction Act

We have outlined significant Medicare changes under the Inflation Reduction Act, including drug price negotiations, Part D redesign, and inflation rebates. We have detailed how specialized guidance supports stakeholders in navigating impacts on commercialization, funding, development, clinical trials, generics, and advocacy.

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