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China Life Sciences Regulation and Compliance

Our Shanghai-based life sciences team provides sophisticated and practical advice on both regulatory and compliance matters. Our capabilities include advice on complex matters relating to life sciences product regulatory policies, as well as the effective development and commercialization of products in China. We also have extensive experience in conducting compliance reviews in China and other jurisdictions in Asia, including investigations of allegations of noncompliance in commercial activities. Our Shanghai-based lawyers work closely with their colleagues in the US and Europe to ensure integrated representation in multijurisdictional matters.

  • Deep Experience: Our team includes a senior lawyer who previously served in the Office of Chief Counsel at the US FDA and at a major biotech company, as well as a senior investigations lawyer who has conducted compliance investigations throughout Asia.

  • Understanding of the Evolving Regulatory Framework: Our Shanghai lawyers closely track developments in China regulatory policies and enforcement, and understand the optimal approaches to achieving success in this challenging jurisdiction.

  • Proactive Compliance Counsel: We understand the emerging risks with respect to the development and commercialization of products in China, and can assist clients in navigating those risks.

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    Healthcare and Life Sciences: Foreign Firms (China) (2023)