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 tough 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, and 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 are able to 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 at 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.
- 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