China represents one of the most important strategic emerging markets for pharmaceuticals and medical device. Accelerating development and time-to-approval to bring new innovative products into China calls for a comprehensive strategy and effective execution. Our local knowledge and insight, combined with our global network, are right there to support your product development needs in China.
- Advising on pathways for early product development to facilitate due diligence decision making in M&A, licensing, and joint venture transactions: Reviewing product profiles, assessing China regulatory issues and providing strategic recommendations.
- Advising on product development strategies and tactical plans for clinical trials and registration in China: Evaluating and providing expert opinions on specific regulatory and clinical program plans including, program and protocol design, and implementation plans to help speed approvals.
- Product development lifecycle advice: navigating China’s regulatory and clinical trial environment: Providing knowledge to support proactive regulatory planning, providing guidance on issues requiring prompt responses
- Regulatory Agency interactions: Developing regulatory meeting strategies, supporting the planning, preparation and organization of formal regulatory meetings and consultations.
- Advising on areas such as CRO/vendor identification and assessment, proper clinical trial set-up and compliance with ICH and Chinese regulations, clinical trial operational issue assessment and resolution, drug safety and pharmacovigilance programs.
- Advising on regulatory policy review, analysis and advocacy initiatives, projects and activities.