Comprehensive assistance to pharmaceutical companies in clinical applications in Japan

     Japan has a mature and efficient healthcare system, providing a broad and stable market foundation for your products. Its sound medical service network and advanced medical facilities provide a favorable support environment for clinical trials and post market promotion of drugs. At the same time, the Japanese government actively encourages innovative drugs to enter the Japanese market, and has had multiple opportunities to obtain PMDA (Pharmaceutical and Medical Devices Agency) information face-to-face during the research and development process.

Our core team members have gathered over 10 years of experience in the Japanese pharmaceutical industry, assisting in the listing and application of four innovative drugs or new indications in Japan. At the same time, I have presided over the PMDA application work for five or more FDA application data packages, and am proficient in data conversion work that meets the requirements of Japanese and American applications.

Our team will work with local CROs in Japan to provide you with the following services:

1. Professional consultation on Japanese drug declaration

2. Bridging between China US Dual Reports and Japan's Declaration

3. Professional writing and conversion of clinical data that meets PMDA standards

4. Comprehensive supervision and management of clinical trials in Japan