Advising Pharmaceutical and Biopharmaceutical Companies
Lee advises domestic and international clients on current and emerging regulatory oversight of biologics and pharmaceutical drug development and manufacturing, including drug-device combination products. She works with clients to address complex issues related to pharmaceutical packaging, drug-device combination products, supply chains, nonclinical toxicology and clinical pharmacology. Lee is skilled in providing strategic counsel on aspects of chemistry, manufacturing and controls (CMC), risk assessment and management strategies, lifecycle management, current good manufacturing practices (CGMPs), and regulatory frameworks for drug master files and other regulatory submissions.
Clients value Lee’s guidance on detailed regulatory requirements for pharmaceuticals as well as on the creation of industry collaborations, including public-private partnerships. She represents industry groups before regulatory agencies and industry and scientific organizations throughout the world, including:
- U.S. Food & Drug Administration
- Health Canada
- European Medicines Association
- United Kingdom Medicines and Healthcare Products Regulatory Agency
- China National Medical Products Administration
- Brazilian Health Regulatory Agency (ANVISA)
- Japan Pharmaceuticals and Medical Devices Agency
- United States Pharmacopeia
Lee is an avid runner, cyclist and hiker. She also enjoys reading mysteries by international authors.