Overview
The life sciences industry is characterized, in large part, by unending innovation driven by the constant demand for new medical therapies. It is equally characterized by a robust but evolving regulatory framework in which the development of new technologies tends to outpace the laws needed to govern them.
In such a dynamic environment dominated by compliance issues and enforcement concerns, savvy legal advice is essential to an organization’s success.
At Epstein Becker Green, we have a tight-knit team of life sciences attorneys and advisors with strong backgrounds in science, industry, and government. Our clients are often on the leading edge of new technologies, and they trust us to guide them in areas where the regulatory picture remains unclear. We help them understand the law and its practical implications so they can adopt workable approaches to their legal, regulatory, and business issues.
Navigating the Regulatory Landscape
In an industry where stringent compliance obligations accompany every facet of a product’s development and commercialization, few companies can navigate the regulatory landscape without help. Our clients look to us to devise an overall regulatory strategy for their product, and we work with them to decide how that strategy will be implemented. How and by whom will the therapy be used? What research will be needed? What claims will need substantiating? What reimbursement schemes make the most sense? The answers to such questions—and countless similar ones—form the basis of each application for regulatory approval and provide our clients with roadmaps for addressing compliance issues going forward.
Our deep understanding of the applicable regulatory bodies and their enforcement mechanisms is key to every aspect of our client service. We represent clients in front of all such bodies, both in routine matters and in investigative inquiries. Our lawyers advise them on the development of their manufacturing and distribution systems. We arrange contracts defining their relationships with customers, vendors, and payors. We review their pricing options and sign off on advertising and promotional communications. Each of these efforts—and much more—is designed to ensure that all operations are fully optimized from both a business and a regulatory standpoint.
Serving Our Clients
Our team of life sciences attorneys and advisors serves organizations across the length and breadth of the life sciences industry, including:
- Academic centers
- Artificial intelligence companies
- Biotechnology companies
- Clinical laboratories
- Combination product manufacturers
- Digital health (IoT) companies
- Food and Dietary Supplements
- Genetics and Genomics
- Human cellular and tissue products (HCT/P) manufacturers
- In vitro diagnostic innovators
- Investors in the life sciences industry
- Medical device manufacturers
- Pharmaceutical and biologic manufacturers
- Precision medicine laboratories
- Research institutions and investigators
- Research services vendors (including contract research organizations and site management organizations
- Suppliers and distributors
- Telehealth companies
- Trade associations and industry coalitions
We cover a broad scope of products and services that fall within these general categories: research and development, clinical research support, product commercialization, FDA regulatory strategy, compliance and training, litigation, and transactions and capitalization.
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Focus Areas
Services
- Academic and Clinical Research
- ADA and Public Accommodations
- Affirmative Action/OFCCP Compliance
- Appellate
- Business Torts, Competition & Trade Secrets
- Class Actions
- Commercial and Contract Litigation
- Corporate & Transactional
- Corporate and Securities Litigation
- Corporate Compliance Program Development, Implementation, and Effectiveness
- Corporate Financing
- Corporate Governance
- Corporate Reorganization
- Cross-Border Data Transfers
- Cross-Border Transactions
- Cybersecurity Risk Assessment
- Data Asset Management
- Data Breach and Incident Response
- Data Breach/Cybersecurity Investigations & Litigation
- Data Protection
- DEI Compliance and Legal Counseling
- Dietary Supplement Litigation
- Digital Health
- Drug and Medical Device Coding, Coverage, and Payment
- Drug and Medical Device Distribution
- Drug and Medical Device Litigation
- Drug Pricing Policy & Reporting
- Employee Benefits and ERISA
- Employment Compliance Counseling
- Employment Litigation
- Employment Training
- Employment, Labor & Workforce Management
- ERISA – Retirement and Benefit Plan Litigation
- Executive Compensation
- FDA Inspections and Enforcement
- Federal Research Grants: Compliance, Investigations & Enforcement
- Financial Restructuring and Bankruptcy
- Foreign Multinational Counseling and Litigation
- General Counsel Services
- Health Care
- Health Care and Life Sciences Investigations and Enforcement
- Health Care and Life Sciences Investor Services
- Health Policy and Legislation
- Immigration
- Industry Research and Clinical Trials
- Insider Threats
- Intellectual Property
- Intellectual Property Litigation
- Internet of Things (IoT)
- Labor and Employment Due Diligence
- Labor Management Relations
- Life Sciences
- Life Sciences Due Diligence
- Litigation & Business Disputes
- Mergers, Acquisitions & Divestitures
- Occupational Safety and Health (OSHA)
- Pandemic Workforce Issues
- Pay Equity
- Privacy Compliance Strategies
- Privacy, Cybersecurity & Data Asset Management
- Product Marketing and Compliance
- Ransomware
- Real Estate
- Regulatory Strategy, Product Development, and Product Approvals
- Remote and Hybrid Work
- Social Media and the Workplace
- State Privacy Law Compliance
- Tax and Tax-Exempt Counseling
- Trade Secrets & Employee Mobility
- Wage and Hour
- Whistleblowing and Compliance
- White Collar Defense and Internal Investigations
- Workforce Government Relations
- Workforce Restructuring and Other Cost-Saving Mechanisms
- Workplace Investigations
Industries
Experience
Our Team
Media
Events
Upcoming Events
- July 24 - 25, 2025
Past Events
Insights
Insights
- Media CoverageEric Neiman Quoted in “Many Medical Treatments Could Be Affected by Supreme Court Transgender Ruling”4 minute read
- BlogsNew OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device5 minute read
- PublicationsDOJ’s Final Rule on Bulk Data Transfers: A Road Map21 minute read
- Media CoverageMarylana Helou Quoted in “HHS Devises Legal Playbook for Future Grant Terminations, Internal Memo Shows”2 minute read
- Media CoverageLisa Pierce Reisz Quoted in “Wearables Take Center Stage in RFK Jr.’s Personal Health Push”3 minute read
- Media CoverageWilliam Walters Quoted in “Some Experts Anticipate PrEP, Other Previous USPSTF Recommendations Could See Age Limits” ...2 minute read
- BlogsDOJ, HHS Announce Revamped False Claims Act Working Group5 minute read
- Publications#WorkforceWednesday: What Employers Need to Know—Key Labor and Employment Developments in Washington State, Ohio, and ...3 minute read
- PublicationsNew York Paid Prenatal Leave: NYC Adds to State Mandate, Imposes More Employer Requirements7 minute read
- Blogs
Master the First Moves in Litigation for Courtroom Advantage – Speaking of Litigation Video Podcast
27 minute read - BlogsTerm Ends with Major Decisions, Including Banning Universal Injunctions - SCOTUS Today15 minute read
- BlogsUpholding State Exclusion of Planned Parenthood from Medicaid, and Three Other Split Decisions - SCOTUS Today10 minute read
- Media CoverageRichard Hughes Quoted in “By Maintaining Obamacare Pillar, Supreme Court Hands Win to HIV Advocates”2 minute read
- Media CoverageRichard Hughes Quoted in “Obamacare Decision Makes Way for Debate on What’s Preventive”2 minute read
- Media Coverage
Richard Hughes Quoted in “Supreme Court Decision on Braidwood Protects Insurance Coverage of Preventive Care” ...
4 minute read - Media CoverageRichard Hughes Quoted in “Gilead, Exact Jump After the Supreme Court Upholds a 'Cornerstone' of Health Care” ...3 minute read
- Firm Announcements
Two Epstein Becker Green Attorneys Named to the 2025 Florida Rising Stars List
6 minute read - Media CoverageRichard Hughes Quoted in “CDC's Overhauled Vaccine Panel Presses on Despite Concerns”8 minute read
- PublicationsWashington Overhauls Employment Laws on Reductions in Force and Background Checks13 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr.’s Real Impact on US Vaccine Supply to Emerge as Panel Meets”2 minute read
- Media CoverageRichard Hughes Quoted in “New-Look ACIP, Down a Member and Homing In on ‘Long-Settled Safety Topics,’ Kicks Off ...5 minute read
- PublicationsDon’t Fall for the Call of Placebo-Controlled Vaccine Trials2 minute read
- BlogsSpilling Secrets Podcast: Legal Shifts in 2025 Put Employer Non-Compete Strategies at Risk2 minute read
- Media CoverageRichard Hughes Quoted in “Balkanization of Vaccine Policy Raises Concerns About Vaccine Uptake, Insurance Coverage ...2 minute read
- Media CoverageMegan Robertson Quoted in “FDA's Makary Breaks Open 'Black Box' On New Podcast”1 minute read
- BlogsDOJ Civil Division Announces 2025 Priorities: Promises “Aggressive” False Claims Act Enforcement of Civil Rights ...6 minute read
- PublicationsSupreme Court Upholds Tennessee’s Ban on Gender-Affirming Care20 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 - BlogsVideo: Workplace ICE Raids Are Surging—Here’s How Employers Can Prepare - Employment Law This Week2 minute read
- PublicationsCMS’ Pay-for-Performance Paradox3 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 “New ACIP Members May Revisit Panel’s Prior Recommendations in Just Two Weeks”4 minute read
- Media CoverageRichard Hughes Quoted in “RFK Jr.'s Rapid Vaccine Agenda Sets Stage to Chip Away at Shots”1 minute read
- Media CoveragePaul DeCamp Quoted in “Trump HR’s New Essay Question Risks Politicizing Federal Hiring”2 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
- BlogsVideo: DOL Restructures - OFCCP on the Chopping Block as Opinion Letters Expand - Employment Law This Week2 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
- Firm Announcements
Epstein Becker Green Recognized by Chambers USA 2025 for Delivering Excellence on Behalf of Healthcare, Labor & Employment ...
5 minute read - Media CoveragePaul DeCamp Quoted in “Injunctions Key Tool in W&H Fights, Birthright Case Illuminates”3 minute read
- PublicationsHHS Secretary Kennedy Told Us Not to Listen to Him. We Agree.2 minute read
- BlogsVideo: Abortion Protections Struck Down, LGBTQ Harassment Guidance Vacated, EEO-1 Reporting Opens - Employment Law This ...2 minute read
- Media CoverageHemant Gupta, Emma Pelkey Quoted in “Utah Targets Mental Health Chatbots as States Scrutinize AI”3 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 CoveragePaul DeCamp Quoted in “DOL Wage Policy Team Brings Biz-Friendly Experience”3 minute read