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 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.
