For more than a century, Morgan Lewis lawyers have helped clients achieve their business goals, and clients have come to rely on the firm for its long tradition of excellence. Though this tradition is important to both our attorneys and our clients, we are focused on the future.

Clients come to us because of our reputation for novel, sophisticated and creative solutions, and because they know that we handle matters involving the latest law and science. When we provide services, we rely on the full range of new technology to maximize client responsiveness and work-product efficiency.

Three aspects of Morgan Lewis’ representation of the life sciences industries distinguish us from our competitors: our ability to represent the full life cycle of FDA-regulated products; our strong science and technology base; and our global perspective and capacities.

From Concept to Commercialization

The FDA/Product Regulation Practice, aided by others at Morgan Lewis, provides companies with all the legal services they need through the entire life cycle of their products, be they drugs, devices, foods, food additives, dietary supplements, food packaging, or other products regulated by the US Food and Drug Administration (FDA) and related US and international agencies. Few other law firms have this full range of capabilities.

We begin by helping companies with corporate organization and financial structuring. In parallel with these early efforts, we also protect intellectual property, as well as tackle the full range of premarket development concerns and strategies. Once FDA approval is obtained, there is a wide array of complicated marketing issues that require attention. For example, we advise clients on:

• strategic and contractual issues involved in joint venturing and licensing;
• the marketing and promotion of products;
• healthcare reimbursement and product pricing;
• antitrust and trade regulation;
• legislative strategies;
• product packaging and labeling;
• Good Manufacturing Practice requirements;
• inspections;
• recalls;
• export and import requirements;
• crisis-management strategies;
• civil and criminal compliance and enforcement matters; and international development and marketing.

We can provide this full life cycle of services because our size and diversity allow us to draw in attorneys from related practices, including our business and finance, patent prosecution and intellectual property, antitrust, legislative, civil litigation, criminal defense, chemical substance, and nuclear regulatory practices.

Grounded in Science and Technology

We know your science and your industry. Our FDA/Product Regulation Practice is one of the largest of its kind. The practice has over a dozen attorneys and regulatory professionals in Washington and in London. Our practice has more than 20 years of experience in regulatory and marketing matters, and we work with approximately 200 companies each year. We have added a regulatory science component to our practice, which is supported throughout the firm by a number of Ph.D.s and other specialists in various toxicology, chemistry, pharmaceutical, physics, engineering and electrical disciplines. This regulatory science practice enhances our ability to advise on the scientific aspects often associated with legal issues affecting the life sciences industries, and also provides the full array of product development services and support needed, particularly by small to mid-sized companies.

Global Solutions

No field is more global than the life sciences industries. Global harmonization has become a critical part of international product development and marketing strategies. Working closely with lawyers in our offices in Europe and Asia, we provide clients with the international scope they need. Because of our global reach, we are able to advise on multinational product development, manufacturing, marketing and post-marketing issues, and assist on transactions in Canada, Europe, non-European countries following the European Union model, and Asia.

Taken together, our ability to represent the full life cycle of FDA-regulated products, our strong science and technology base, and our global perspective and capacities differentiate and distinguish Morgan Lewis from our competitors and allow us to provide superior, comprehensive and sophisticated advice to a wide variety of regulated entities.

Morgan Lewis is uniquely qualified to represent companies in the life sciences industries. Our Food and Drug Administration and Product Regulation Practice, supported by other practice areas in the firm, provides the full spectrum of legal services for the complete life cycle of FDA regulated products. We work with companies from planning their preliminary organization and financial structuring, through the entire life cycle of product approval and domestic and global marketing and distribution.

Our strong science and technology base includes specialists in various toxicology, chemistry, pharmaceutical, physics, engineering and electrical disciplines relevant to the life sciences industries. Few other law firms can match this range of capabilities.

No field is more global than the life sciences industries. With offices worldwide, our international perspective and experience enables Morgan Lewis to provide creative legal services and comprehensive support to both large and small companies in the life sciences industries.