1）In order to ensure stable process and controllable quality of service results, we have established a R&D quality management system in accordance with cGMP, GLP and other requirements, and strictly manage the laboratory site and records to ensure the integrity of data.

2）According to NMPA, FDA, ICH and other technical requirements, we strictly manage the R&D process and submit high-quality submission dossier.

3）WBS (work breakdown structure) is carried out according to output requirements. We break down the target tasks into various research phases: route opening and optimization, lab-scale study, pilot-scale study, pilot manufacturing, and process study.

4）In order to ensure the updating of knowledge, we always pay attention to the development of drug regulatory authorities in different countries or regions, and carry out internal training and communication on a regular basis.

By means of information technology and software systems and platforms such as OA, ERP, CRM, BMS, EMS and LIMS, the quality control of the whole production process is ensured while the operation and management level and efficiency are greatly improved. All documents, personnel operations, data, instruments, equipment, environment and products are under compliant and traceable monitoring to satisfy the requirements of international and domestic registration and declaration.