Authors: Liming Fang, Emi Akatsu, Phillip Johnston
Founded in 2016, Zhejiang Longcharm Biomedicine Technology Co., Ltd. provides one-stop R&D outsourcing services for the Chinese pharmaceutical industry. They can support BA/BE/PK clinical testing and data analysis services that comply with Chinese and American regulatory requirements for both novel and generic drug development programs.
In 2023 July, Zhejiang Longcharm Bio-medical Technology Co., Ltd (Longcharm Bio), a well-known contract research organization (CRO) in China, decided to implement Pinnacle 21 Enterprise to optimize and streamline the internal regulatory review system. Pinnacle 21 Enterprise helps Longcharm Bio to qualify validation data and comply with CDISC standards, providing a high-quality, effective data pipeline from sponsors to regulatory agencies. Improving the efficiency of regulatory document review will also help Longcharm Bio accelerate new product launches.
We interviewed Liming Fang, Deputy General Manager, Longcharm Bio and Philip Johnston, Director of Product at Certara to learn more.