Overview
For life sciences companies developing new technologies and treatments that improve lives, success hinges on far more than following the letter of the law. At Epstein Becker Green, we translate legal advice into practical action. Our team of lawyers and non-lawyer consultants and advisors offers real-world experience from careers in all corners of the life sciences industry.
We understand the unique legal, regulatory, compliance, operations, and technology challenges facing life sciences companies. Because of the diversity and breadth of experience of our Life Sciences team, we successfully meet the needs of our life sciences clients, from early pre-clinical research to commercialization and product launch through commercial operations, providing support for compliance with legal requirements over the entire product lifecycle. Our clients include pharmaceutical, biotechnology, medical device, and other life science industry companies.
Use Our Integrated Approach to Your Advantage
Life science companies require practical and comprehensive support as they discover, develop, and commercialize novel medical technologies to meet the needs of patients. Our attorneys partner with our affiliate, EBG Advisors, giving clients unrivaled access to non-lawyer consultants and advisors. Working as an extension of our firm, a diverse team of former physicians, health plan medical directors, reimbursement specialists, quality and regulatory experts, and government agency officials leverage their insight to tackle challenging regulatory hurdles.
Research and Development Solutions with Lasting Results
Tomorrow’s medical breakthroughs are founded on today’s innovative research. Clients turn to us for advice on the best way to secure investments for new research and to structure collaborative research and development transactions. We also negotiate collaboration terms, clinical site contracts, and services agreements with contract research organizations and other research services vendors.
Sophisticated Counsel for Corporate Transactions
Life sciences clients looking to grow or sell their companies count on us to help them evaluate targets for mergers, acquisitions, joint ventures, and sales, as well as to successfully structure and close their deals. We also represent private equity funds and other investors in financing transactions with life sciences companies. Because we have in-depth knowledge of the life sciences industry, and the laws and regulations that apply to it, we can easily spot and resolve potential problems that can arise during these transactions.
Corporate Compliance and Training Programs That Support Growth
In the fast-paced life science landscape, compliance programs are never static and may cover multiple jurisdictions spanning various supply chains and numerous third parties. While no two compliance programs are alike, risk management drives a company’s ability to anticipate enforcement agency priorities. We help clients define and assess their risks and develop compliance infrastructure and training programs that support their business goals.
Litigation and Dispute Resolution Services to Protect Your Interests
The complexity of the highly regulated life sciences industry has increasingly led to litigation among life sciences companies and their competitors, collaborators, consumers, and others, as well as by federal and state law enforcement agencies and qui tam relators. Our litigation attorneys, including some with high-level governmental prosecutorial backgrounds, are experienced in guiding life sciences clients through investigations, enforcement actions, and lawsuits. We represent and defend our clients in federal and state trial and appellate courts and before administrative and private tribunals in civil and criminal cases.
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Focus Areas
Services
- Academic and Clinical Research
- Artificial Intelligence
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Digital Health
- Drug and Medical Device Coding, Coverage, and Payment
- Drug and Medical Device Distribution
- Drug Pricing Policy & Reporting
- FDA Inspections and Enforcement
- Federal and State False Claims Act (Including Qui Tam)
- Federal Research Grants: Compliance, Investigations & Enforcement
- General Counsel Services
- Health Care and Life Sciences Investigations and Enforcement
- Health Care and Life Sciences Investor Services
- Health Care Mergers and Acquisitions
- Health Policy and Legislation
- Industry Research and Clinical Trials
- Life Sciences Due Diligence
- Mergers, Acquisitions & Divestitures
- Product Marketing and Compliance
- Regulatory Strategy, Product Development, and Product Approvals
Industries
Experience
Our Team
Media
Events
Past Events
Insights
Insights
- BlogsDOJ Civil Division Announces 2025 Priorities: Promises “Aggressive” False Claims Act Enforcement of Civil Rights ...6 minute read
- Firm Announcements
Epstein Becker Green Earns Top Honors in Legal 500 2025 for Excellence in Client Service and Achievements Across Key Health ...
3 minute read - PublicationsSupreme Court Upholds Tennessee’s Ban on Gender-Affirming Care20 minute read
- Media CoverageRichard Hughes Quoted in “New ACIP Members May Revisit Panel’s Prior Recommendations in Just Two Weeks”4 minute read
- Media CoverageRichard Hughes Quoted in “How Kennedy’s Purge of Advisors Could Disrupt U.S. Vaccinations”2 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr.'s Rapid Vaccine Agenda Sets Stage to Chip Away at Shots”1 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr.’s Moves Leave Insurance Coverage of Vaccines in Doubt”2 minute read
- Media CoverageRichard Hughes Quoted in “Kennedy Announces Eight New Members of CDC Vaccine Advisory Panel”2 minute read
- PublicationsVaccine Policy in Crisis: Secretary Kennedy Dismisses Entire Advisory Committee on Immunization Practices3 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr.'s Vaccine Advisory Overhaul Undermines Vaccine Confidence, Experts Say”7 minute read
- Media CoverageRichard Hughes Quoted in “Health Secretary RFK Jr. Abruptly Fires CDC Vaccine Advisory Panel”4 minute read
- BlogsA Final Rule Bites the Dust, Part II: FDA Gives up on Regulating LDTs as Medical Devices4 minute read
- Media CoverageRichard Hughes Quoted in “Big Bill, Big Coverage Losses: Vaccines–Codifying ACIP?”2 minute read
- PublicationsHHS Secretary Kennedy Told Us Not to Listen to Him. We Agree.2 minute read
- PublicationsAn Uncertain Vaccines Market Keeps Getting Dicier2 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr. Fires ‘Opening Salvo’ on Vaccine Status Quo”7 minute read
- Media CoverageRichard Hughes Quoted in “CDC Contradicts Kennedy and Keeps Advice That Children May Get Covid Shots”2 minute read
- Media CoverageRichard Hughes Quoted in “CDC Recommends Parents Talk to a Doctor About Getting COVID-19 Shots for Kids”5 minute read
- Media CoverageRichard Hughes Quoted in “What to Know About COVID Vaccines for Children, Pregnant Women After RFK Jr.’s Change” ...7 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr. Puts Health Insurers in Limbo by Dropping Covid-19 Shot”5 minute read
- Media CoverageRichard Hughes Quoted in “Some 300 West Virginia School Vaccine Exemptions Granted Under New, Laxer Policy” ...3 minute read
- Media CoverageRichard Hughes Quoted in “The FDA May Restrict Covid Shots. Who Will Be Able to Get Them?”2 minute read
- BlogsDOJ Civil Rights Fraud Initiative: FCA Enforcement Expanding Into Alleged Discrimination6 minute read
- BlogsUtah Law Aims to Regulate AI Mental Health Chatbots8 minute read
- Media CoverageRichard Hughes Quoted in “FDA Set to Unveil New Covid Vax Guidelines Today”3 minute read
- Media CoverageElizabeth McEvoy Quoted in “NSF Plan to Slash ‘Indirect’ Science Funding: Will It Stick?”6 minute read
- PublicationsThe Final Rule on Research Misconduct Regulations: What Institutions Need to Know as Implementation Looms24 minute read
- Media CoverageRichard Hughes Quoted in “Vaccines Face Uncertain Approval, Reviews with New FDA Official”3 minute read
- Media CoverageRichard Hughes Quoted in “Does the CDC Have an Acting Director?”6 minute read
- Media CoverageGary Baldwin, Karl Thallner Featured in “2 Health Care Regulatory Attorneys Move to Epstein Becker Green”2 minute read
- Media CoverageRichard Hughes Quoted in “HHS to Stop Recommending Routine Covid Shots for Children, Pregnant Women”5 minute read
- BlogsNational Science Foundation (NSF) Imposes 15% Indirect Cost Rate Cap: What to Know7 minute read
- BlogsWill Colorado’s Historic AI Law Go Live in 2026? Its Fate Hangs in the Balance in 20258 minute read
- BlogsColorado’s Historic AI Law Survives Without Delay (So Far)8 minute read
- BlogsEleventh Circuit Addresses Rule 9(b) Heightened Pleading Standard in False Claims Act Case5 minute read
- Media CoverageRichard Hughes Quoted in “States Loosen Vaccine Rules — Even as Measles Outbreak Rages”8 minute read
- Firm AnnouncementsEpstein Becker Green Welcomes Seasoned Health Care Regulatory Attorneys Gary L. Baldwin and Karl A. Thallner, Jr ...3 minute read
- Media CoverageGary Baldwin, Karl Thallner Featured in “Healthcare Duo Joins Epstein Becker Green”2 minute read
- BlogsVideo: Federal Court Strikes Down FDA Rule on LDTs – Thought Leaders in Health Law2 minute read
- Media CoverageRichard Hughes Quoted in “Kennedy Issues Demands for Vaccine Approvals That Could Affect Fall Covid Boosters” ...2 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr.’s Latest Vaccine Plan Threatens Future of Shots, Experts Say”2 minute read
- PublicationsNewborn Screening at Risk: Implications of Disbanding the Advisory Committee on Heritable Disorders in Newborns and ...4 minute read
- PublicationsThe Future of Preventive Care Depends on the Supreme Court’s Reading of Two Words2 minute read
- Media CoverageRichard Hughes Quoted in “SCOTUS Weighing Braidwood Appointments Clause Violation in Briefs Request”2 minute read
- Media CoverageRichard Hughes Quoted in “Survival of Preventive Care Coverage Mandate Would Boost Some Health Care Firms”2 minute read
- Media CoverageRichard Hughes Quoted in “Why Journalists Need to Explain the Value of No-Cost Preventive Care”7 minute read
- BlogsPodcast: Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care2 minute read
- Media CoverageWilliam Walters Quoted in “Ruling Could Give Kennedy More Power Over Health Care Coverage”4 minute read
- Media CoverageRichard Hughes Quoted in “ACA Preventive Care Case Reaches Supreme Court”4 minute read
- Media Coverage
What's at Stake as Oral Arguments Are Presented in the Braidwood Case? Q&A with Richard Hughes, IV
4 minute read