Regulatory Affairs & Clinical Trial Management.

Most market entry strategies in China need to go hand-in-hand with an appropriate regulatory approach and strategy. We will provide the necessary guidance advising our clients on how to best navigate the China regulatory environment — whether you need help consulting on China’s NMPA medical devices classification or on the procedure for Import Drug NMPA Registration or simply the definition of health food products in China and the health food products NMPA Registration process.

According to NMPA ‘s rules and regulations, we can provide China regulatory consulting and product registration services in China including pharmaceuticals, healthcare products, international clinical trials, cosmetics, and medical devices. We will first conduct a feasibility study to ensure a successful application and registration under such circumstances that efforts, cost, and time are radically reduced.

We also assess the regulatory capabilities of potential China distributors and partners to take the fast route to China market. We also provide time efficient and cost effective services in clinical trial management in alliance with some of the best clinical trial institutes and organisations in China to meet the standards and requirements of US FDA, UK MHRA, EU EMA and China NMPA.

Our services are specialised in:

• Regulatory Strategy Development
• Clinical trial project management