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
Representative Experience
Our Team
Media
Events
Upcoming Events
Past Events
- March 30 to April 2, 2026
- March 18 - 20, 2026
Insights
Insights
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