Katherine Wang is a partner in our life sciences group. Widely regarded as a leading life sciences regulatory lawyer in China, Katherine assists pharmaceutical, biotechnology, and medical device companies on a wide range of matters, including early-stage discovery, product registration, regulatory/GxP compliance, pricing, reimbursement, clinical studies, promotional practices, product safety issues, government investigations, and risk assessments. Katherine provides day-to-day counseling on issues that life sciences companies face in relation to their interaction with agencies including the National Medical Products Administration (NMPA, formerly the CFDA), the National Health Commission (NHC) and the State Administration of Market Regulation (SAMR), among others. She also assists institutional investors and corporate clients in structuring transactions and conducting regulatory due diligence, including good laboratory practice (GLP), good clinical practice (GCP), good manufacturing practice (GMP) and pharmacovigilance, on investment targets and prospective business partners in China. Recently Katherine has provided critical guidance to clients on a variety of legal and regulatory issues associated with the COVID-19 pandemic, including advising on regulatory requirements related to PPE export and the development of drugs or vaccines, and helping clients navigate evolving developments in the life sciences industry.
Before entering into private practice, Katherine served as the head of AstraZeneca’s legal department in the Asia-Pacific region. In this role, she advised on critical strategic and operational initiatives to ensure legal compliance and realization of business objectives. She was also responsible for cross-functional intellectual property enforcement and anti-counterfeiting efforts.