Bioanalytical Services

The core technical team has years of professional experience in biopharmaceutical analysis from leading global biotechnology/pharmaceutical companies.

The core technical team is familiar with various biopharmaceutical analysis methods and R&D processes, well-versed in domestic and international project application and regulatory requirements. With successful experiences in obtaining regulatory approvals for 9 biopharmaceuticals in Europe and the United States and 5 biopharmaceuticals in China, our expertise covers preclinical and clinical phases (Phase I, II, III) of innovative biopharmaceuticals and biosimilars. We have undergone multiple reviews by the FDA, EMA, and CFDI.

Regulatory policies are becoming increasingly stringent, with higher scientific requirements for analytical methods by regulatory agencies.

In recent years, regulatory agencies both domestically and internationally have issued various guidelines and documents related to biopharmaceutical analysis, resulting in more stringent regulatory requirements. Compared to other domestic CROs, our core technical team has unique experience and advantages in developing biopharmaceutical analysis methods. We can effectively address the deficiencies in method development for domestic clients, significantly improving detection efficiency, accelerating the clinical trial process, saving valuable time in drug development, and meeting the declaration requirements of domestic and international regulatory agencies.

The team has extensive experience in managing analytical laboratories, familiar with various technical platforms, and compliant laboratory management systems. It has the capability to provide comprehensive end-to-end services.

With comprehensive technical platforms, we can fully support preclinical and clinical pharmacokinetics, pharmacodynamics, immunogenicity, and biomarker research. We have the complete capability to provide end-to-end services, including the development and validation of biopharmaceutical analysis methods, analysis of preclinical and clinical samples, data analysis, and regulatory submission.

Our well-established laboratory management system ensures automation, electronic record-keeping, and systemization in the major steps of testing and analysis, effectively avoiding human errors and information omissions. Additionally, through the customized design of professional equipment and facilities, we further enhance the efficiency and accuracy of testing and analysis, fully complying with the analytical regulations of China’s NMPA, the European Union’s EMA, and the United States’ FDA.