Areas of Practice

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 helps clients respond to inquiries from regulatory bodies around the world, including China’s National Medical Products Administration, the National Health Commission, the State Administration of Market Regulation, and the United States Food and Drug Administration. 

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 Asia’s life sciences markets. 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 counsel to academic medical centers on a variety of legal and regulatory issues associated with their cross-border research and healthcare service delivery activities. These issues include cross-border transfer of personal data and biological materials, telemedicine, remote second opinions, and patient referrals from Asia.

She is an integral member of an Asia-focused life sciences team that is consistently ranked in the top bands of Chambers Asia-Pacific Region, Chambers Greater China Region, Chambers Global and The Legal 500 China guides.


Select 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-related support

  • 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

Select Experience in Asia includes:

  • Advised a global top 3 pharmaceutical company on its sale of a mature product portfolio and marketing authorization transfer in Hong Kong, Taiwan, Macau, Japan, Korea, Thailand, Vietnam, Malaysia, Singapore, and the Philippines
  • Advised a China-headquartered biopharmaceutical company on cross-border transfer of clinical study data in Australia and Japan
  • Advised a healthcare-focused private equity fund and its portfolio company on data privacy issues in Australia
  • Advised a European medtech company on the collection of serum samples in Japan and Singapore for quality control of its IVD reagents
  • Advised a leading US academic medical center on patient referral and telemedicine services in Greater China
  • Advised an Israeli manufacturer of medical aesthetic products on importation of unapproved equipment for personal use in Japan
  • Advised a US-based biopharmaceutical company on marketing authorization application and transfer strategies in China, Singapore and Vietnam
  • Advised a US-based biopharmaceutical company on export of human biological materials from Thailand and the Philippines
  • Advised a China-headquartered biopharmaceutical company on marketing authorization transfer issues in Australia and Singapore
  • Advised a multinational biopharmaceutical company on clinical research compliance and data privacy issues in Taiwan
  • Advised a world-leading consumer electronics company on clinical research ethics of a user monitoring study in Hong Kong and Australia
  • Advised several US-headquartered pharmaceutical companies on post-study drug access and compassionate use program in Hong Kong

Areas of Practice