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.
Read less
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
Insights
Insights
- Media CoverageErik Weibust Quoted in “US FTC Votes Through Non-Compete Clause Ban Spelling Uncertainty for Trade Secret Strategy” ...2 minute read
- Media CoveragePeter Steinmeyer Quoted in “New Ban on Noncompetes Could Have Big Impact on Health Care”4 minute read
- Media CoverageGenevieve Murphy-Bradacs Quoted in “EEOC Criminal History Suit Brings Fresh Focus to Old Policy”3 minute read
- Media CoverageJeff Ruzal Quoted in “New Overtime Rule Raises Salary Level in Two Phases”2 minute read
- Media CoverageErik Weibust Quoted in “Takeaways from the FTC's Noncompetes Ban”2 minute read
- BlogsVideo: SCOTUS Expands Title VII, EEOC’s Final PWFA Rule, AI Screening Tools - Employment Law This Week3 minute read
- Media Coverage
Kate Heffernan Featured in AHLA’s Speaking of Health Law Podcast, “Trends Related to Research Misconduct” ...
1 minute read - Media CoveragePeter Steinmeyer Quoted in “Businesses Face ‘Seismic Shift’ After FTC Bans Noncompetes. Here’s What They Should Do ...2 minute read
- Media CoveragePeter Steinmeyer Quoted in “For Traders, the FTC Ban on Non-Competes Comes with Big Catches”2 minute read
- Firm Announcements
Fourteen Epstein Becker Green Attorneys Named to the 2024 Washington, DC, Super Lawyers and Rising Stars Lists
7 minute read - Firm AnnouncementsEpstein Becker Green’s Consistent and Enthusiastic Support of AHLA Reflected in the 2024 Top Honors List2 minute read
- Media CoveragePaul DeCamp Quoted in “Federal Rules, State Action Complicate In-House Labor Strategies”3 minute read
- Media CoverageHelaine Fingold Quoted in “Finalized Broker Pay Cap Appears to Exclude FMOs, but Impact Remains Unclear”2 minute read
- Firm Announcements
Epstein Becker Green Recognized Among Largest Health Care Law Firms by Modern Healthcare
1 minute read - Media CoverageAmy Lerman Quoted in “What the House Subcommittee Hearing Tells Us About Telehealth’s Future”2 minute read
- Firm Announcements
Epstein Becker Green Recognized as a Premier Client Service Provider by Corporate Counsel – BTI A-Team 2024 Report ...
2 minute read - BlogsFDA Releases Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements6 minute read
- BlogsVideo: Union Reps at OSHA Inspections, New COVID-19 Guidance, and Minimum Wage Updates - Employment Law This Week2 minute read
- Media CoverageTheodora McCormick Quoted in “‘Vague’ NY Law Looms for the Vitamin Shoppe, Other Supplement Retailers”3 minute read
- Media CoveragePaul DeCamp Quoted in “Use of Injunctions Against Agency Rules Raises Eyebrows”3 minute read
- BlogsVideo: New DOL Rules, U.S. Government Changes Race and Ethnicity Categorization - Employment Law This Week2 minute read
- Media CoverageTeddy McCormick Quoted in “NPA to Seek Injunction Against NY Law Related to Weight Loss Supplements”4 minute read
- BlogsUnpacking Averages: Adverse Events for Device-Lead Combination Products7 minute read
- Media CoverageSteve Swirsky Quoted in “Judge’s Decision Not the End for NLRB’s Joint Employer Efforts, Attorneys Say” ...5 minute read
- BlogsVideo: How Can Employers Prepare for the Future of Pay Equity? - Employment Law This Week2 minute read
- PublicationsComma, Comma, Comma, Comma, Comma Chameleon: How Punctuation Can Color IP & Other Legal Rights4 minute read
- BlogsLast Call for Comments on the Bipartisan Discussion Draft of the SUSTAIN Act: Shaping 340B for the Future10 minute read
- Blogs
“They Said What?! I’ll Sue!” – Litigating Defamatory Claims – Speaking of Litigation Video Podcast
25 minute read - Media CoverageWes Scott Featured in "In Charge 2024: Finance"1 minute read
- Firm Announcements
Fifteen Epstein Becker Green Attorneys Named to the 2024 New Jersey Super Lawyers and Rising Stars Lists
5 minute read - BlogsFDA Releases Draft Guidance on New Dietary Ingredient Notification Procedures, Timelines11 minute read
- Media Coverage
Epstein Becker Green Attorneys Elected to Law360’s 2024 Editorial Advisory Boards
3 minute read - PublicationsFDA and OHRP Issue Joint Draft Guidance on Content, Organization, and Presentation of Consent Forms for Research ...9 minute read
- Media CoverageDavid Shillcutt Quoted in “Decline in EBSA Funding May Hurt Mental Health Parity Efforts”2 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