Today, life sciences companies are exploring expanded opportunities created by advances in genetics knowledge, research design, computer modeling, big data analytics, mobile devices and apps, global communications, personal communications, cloud-based processing and storage and other technologies. Those opportunities raise new types and levels of risk through increased complexity of products and product delivery systems, as well as expanded regulation, compliance enforcement and litigation.
We have professionals who represent fast-growing clients that use life science technology to create products for health and wellness, healthcare, food production, environmental and other applications. Examples are those in the following sectors: small-molecule pharmaceuticals, biologicals, vaccines, biotechnology, medical devices, diagnostics, veterinary products, foods, nutritional supplements, medical and nonmedical research, personal care products, pharmacies and other distributors of pharmaceutical and medical device products.
Our attorneys team with clients to advance opportunities and mitigate risks in all product lifecycle phases — from early development and registration through approval, marketing and disposal. We regularly join forces to work with life sciences clients on matters involving the activities and entities listed below.
- Corporate formation
- Mergers and acquisitions
- Venture capital
Regulatory counseling and litigation
- Centers for Medicare & Medicaid Services (CMS)
- Controlled-substance regulation
- Food and Drug Administration (FDA)
- Federal Trade Commission (FTC)
- Government relations and policy advocacy
- International trade (U.S. customs, import, and export)
- Medicare and Medicaid issues
- Office of Inspector General (OIG)
- Pharmacy regulation, licenses, and permits
- Real estate transactions
- Securities regulation, compliance, and enforcement
- Trade associations
- U.S. taxation