Life Sciences
Introduction
Exceptional Experience
Our practice group has long provided comprehensive legal support to domestic and international pharmaceutical, medical device, and healthcare clients. We advise on all aspects of medical care and product-related matters, including procurement, pricing investigations, clinical trials, marketing and promotion, product registration, drug relief, and healthcare disputes. We also assist pharmaceutical and medical device associations in regulatory compliance, enforcement, and dispute resolution, with deep familiarity in industry practices. Our expertise extends to tobacco, alcohol, food, cosmetics, pesticides, veterinary drugs, feed, and pet food sectors.
Key Strengths
Serving predominantly multinational life sciences and healthcare firms, we bring extensive experience navigating ethical standards, SOPs, and industry-specific requirements throughout the product lifecycle. We help clients develop forward-looking strategies addressing digital health, precision medicine, regenerative therapies, and AI-driven innovations, ensuring alignment with rapidly evolving technologies and regulatory landscapes. Our tailored approach meets the unique needs of each client.
Solution-Based Advice
We regularly assist clients in formulating and executing strategic legal actions. We provide timely, precise, and practical solutions tailored to the specialized demands of the industry. Collaborating closely with clients' Legal, Compliance, and Regulatory Affairs teams, we integrate cross-functional risk management and internal controls across all stages and dimensions of their operations. Our team is also well-versed in investigations, seizures, and prosecutions involving counterfeit or prohibited drugs, as well as patent protection, patent linkage, and generic competition.
Scope of Services
- Regulatory advice on marketing authorization, market entry, project import, EUA of drugs and medical devices, government taking, liability for compensation, and regulatory protection of drugs (data exclusivity and market exclusivity)
- Consultation regarding drug listing, determination and adjustment of reimbursement price, and PVA/MEA under national health insurance
- Marketing and promotion of drugs and medical devices, regulatory consultation on drug listing in procurement and contract review, and patient support programs
- Clinical trial, human subject research, authorization and use of medical/healthcare information, and cell therapy related legal consultation and contract review
- Consultation on adverse reaction reporting of drugs and medical devices, drug injury relief, and relevant dispute
- Consultation on licensing, technology transfer, OEM/ODM of drugs and medical devices, and contract review and due diligence thereof
- Negotiation of drugs and medical devices distribution/consignment agreement (including 3PL and 4PL)
- Regulatory advice on market entry, post-marketing product liability, and recall of food, animal drug, tobacco, alcohol, and other consumer products, and administrative investigation and related administrative remedy
- Practical regulatory solutions addressing digital health, precision medicine, regenerative therapies, and AI-driven innovations