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, the need for 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 not just the law, but also 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 both 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 we sign off on advertising and promotional communications. All of these efforts—and much more—are 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 (CROs) and site management organizations (SMOs))
- 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
- Construction Law
- 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
- Dietary Supplement Litigation
- Digital Health
- Diversity, Equity & Inclusion Counseling
- 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
Past Events
- February 5–7, 2024
- November 29, 2023
Insights
Insights
- PublicationsFDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research ...9 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Warned of Removing Guidance Comment Period in Proposed Plan”2 minute read
- Firm AnnouncementsEpstein Becker Green Continues to Materially Expand Employee Benefits and Executive Compensation Capabilities with ...3 minute read
- BlogsFifth Circuit Poised to Uphold Ruling Striking Down Preventive Coverage Requirement4 minute read
- BlogsMaking Moves – FDA’s LDT Proposed Rule Sent to OMB for Review2 minute read
- Firm AnnouncementsEpstein Becker Green Named Among “Leading Edge Law Firms” by BTI Consulting Group2 minute read
- BlogsUnpacking Averages: Analyzing FDA’s Performance in Finalizing Guidance Documents14 minute read
- Publications
Will Religious Freedom Claims Trump Public Health? Braidwood and HIV Prevention
2 minute read - Firm Announcements
Three Epstein Becker Green Attorneys Cited for Noteworthy Thought Leadership in JD Supra 2024 Readers’ Choice Awards ...
4 minute read - Media CoverageRichard Hughes Quoted in “ObamaCare Faces Key Hearing After Texas Ruling”2 minute read
- Media CoverageRichard Hughes Quoted in “4 Argument Sessions Benefits Attys Should Watch in March”4 minute read
- BlogsVideo: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – ...2 minute read
- Media CoverageRichard Hughes Quoted in “Affordable Care Act Preventive Services Under Threat: Previewing Braidwood Oral Arguments” ...4 minute read
- Blogs
Privacy Officer's Roadmap: Data Breach and Ransomware Defense – Speaking of Litigation Video Podcast
42 minute read - BlogsIn Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute11 minute read
- Media CoverageRichard Hughes Quoted in “Doc Pay Patch Could Emerge in Scaled-Back Health Package; Budget Talks Continue”2 minute read
- BlogsFDA Releases Updated Directory on Select Dietary Supplement Ingredients5 minute read
- Firm AnnouncementsEpstein Becker Green’s Complimentary Wage & Hour App Provides Employers with Updates on Key Laws for 20243 minute read
- Media CoverageBob Hearn Quoted in “Concerns Mount as More States Adopt Biomarker Laws”2 minute read
- Media CoverageDavid Shillcutt Quoted in “Growth in Outpatient Programs Signals Opportunities for MFTs, MHCs”2 minute read
- Media CoverageMegan Robertson Featured in “Women in STEM: The Stories of Five Women Scientists with Clemson Ties”4 minute read
- BlogsNJ Approves Cannabis Regulatory Amendment with Major Impacts on Class 5 Retail License Holders6 minute read
- BlogsUnpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are ...10 minute read
- Media CoveragePaul DeCamp Quoted in “Ambiguity Is Key to Triggering Agency Deference”3 minute read
- PublicationsHealth Care M&A Insights: Q4 2023 & Outlook for 2024 Deal Activity4 minute read
- PublicationsNYC ESSTA’s New Private Right of Action Gives Employers a Reason for Action … to Review Safe and Sick Leave Policies ...11 minute read
- Media CoverageJeff Ruzal Quoted in “1 Way to Wrap Up Wage-Hour Suits Without Court Review”3 minute read
- PublicationsSponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement13 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
- Media CoverageWes Scott Featured in “People on the Move”1 minute read
- Media CoverageWes Scott Featured in “Legal Notes: New Partners”2 minute read
- Media CoverageBradley Merrill Thompson Discusses Clinical Decision Support, Medical Devices, and AI in Yale Video1 minute read
- PublicationsReminder for New Jersey Employers: Review Employment Law Updates and Poster Requirements for 202419 minute read
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved” ...2 minute read
- PublicationsNew York State Follows New York City in Enacting Freelance Worker Protections9 minute read
- BlogsUnpacking Averages: The Seasonality of FDA 510(k) Decision-Making and the Impact of Michigan Playing for a National ...10 minute read
- Media CoverageJames Boiani Quoted in “FDA Braces for High Court, Final Rule Moves in Election Year”3 minute read
- Firm AnnouncementsEpstein Becker Green Expands Capabilities in Nashville with M&A Attorney Wes Scott3 minute read
- Media CoverageWes Scott Featured in “Epstein Becker Adds M&A Specialist to Health Care Practice in Nashville”4 minute read
- PublicationsCorporate Transparency Act Brings Expansive New Federal Reporting Requirements for Entities in 202419 minute read
- PublicationsNew Year, New Changes for California Employers in 202422 minute read
- Media CoverageRichard Hughes Quoted in “The RSV Shot for Babies Was Supposed to Save Lives. Then Nobody Could Get It.”13 minute read
- PublicationsMaking Sense of New Paid Leave Obligations in Illinois – Coming SOON26 minute read
- Media CoverageAlaap Shah Quoted in “2024 Outlook: The Cybersecurity Trends Health System Leaders Need to Know”3 minute read
- PublicationsNew York Further Restricts Agreements Involving Claims of Discrimination, Harassment, or Retaliation8 minute read
- Media CoverageDelia Deschaine Quoted in “How the FDA Could Boost Gender-Affirming Care”5 minute read
- Media CoverageDavid Shillcutt Quoted in “4 Major Benefits Policy Developments from 2023”3 minute read
- Media CoveragePaul DeCamp Quoted in “Judges Order Arrests in Rare Labor Agency ‘Punch’ Over Defiance”2 minute read
- Media Coverage
Featured in Los Angeles Sentinel: Attorney Kimberly Carter Joins Epstein Becker Green Law Firm
1 minute read - Media Coverage
Featured in Law360: Employment Attorney Kim Carter Joins Epstein Becker Green
2 minute read