Widely regarded as a leading lawyer in the life sciences space, Katherine Wang provides global companies and investors with cutting-edge regulatory, compliance and enforcement advice. She draws on more than 25 years of experience in the Asia-Pacific region—including five years as head of legal affairs for a global pharmaceutical company.
Multinational pharmaceutical, biotechnology and medical device clients seek Katherine’s counsel on all phases of the product life cycle, from clinical studies and market access to product manufacturing and promotion. She also helps clients respond to inquiries from regulatory bodies, including China’s National Medical Products Administration, the National Health Commission and the State Administration of Market Regulation.
In addition, Katherine routinely advises institutional and corporate investors. In this capacity, she coordinates regulatory due diligence on investment targets and prospective business partners and advises on the regulatory aspects of complex life sciences transactions. She possesses a deep understanding of the strategic and operational issues at play in China’s life sciences market. Clients view Katherine as “highly professional and solutions oriented” (The Legal 500), and appreciate her ability to “provide down-to-earth legal advice” and her “good sense of business" (Chambers Greater China).
Katherine also provided critical counsel to clients on a variety of legal and regulatory issues associated with the COVID-19 pandemic. Most recently, Katherine has been advising life sciences clients on cybersecurity, data privacy, and digital health—emerging areas within the legal landscape of the Asia-Pacific region.
Selected experience includes:
Life sciences regulatory and compliance counseling
Experience includes representing or advising life sciences and multinational pharmaceutical companies in respect of their operations in the Asia-Pacific:
- on entry strategies and market access issues
- in matters relating to their clinical research compliance
- with localization of product manufacturing
- on promotional practices
- on issues relating to generic entry or biosimilar strategies, product life cycle management, and regulatory exclusivity
- on the general regulatory environment concerning OTCs, cosmetics (including medical aesthetics), dietary supplements and veterinary drugs
Life sciences regulatory enforcement
Experience includes assisting multinational pharmaceutical and medical device companies with:
- preparing for potential onsite inspections by the Human Genetic Resources Administration of China
- government inquiries associated with non-conformity to China’s mandatory product standards and specifications
- responses to investigations initiated by China’s National Medical Products Administration on the supply of unapproved products to healthcare institutions
- on site audits initiated by Chinese regulatory authorities on potential violations of the Good Manufacturing Practices and Good Sales Practices
Digital health & data privacy matters
Experience includes representing or advising:
- Global life sciences companies and investment funds on data privacy and cybersecurity issues in the Asia Pacific
- Leading U.S.-based healthcare service providers on their telemedicine offerings in China
- Medical technology companies on the development and commercialization of digital therapies, AI-based diagnostic equipment and instruments, internet-based or mobile patient interfaces, collaborations with hospitals for the collection of clinical and health data, cross-border data transfer, and patient privacy issues
- Life sciences and high-tech companies on digital health product approvals in China
- Deal structuring and regulatory due diligence in compliance with regulatory requirements of key markets in the Asia Pacific
- Regulatory counseling on ad hoc issues arising in connection with transactions
- Counseling investor clients on post-investment compliance of portfolio companies’ operations in China