Quality system management with high quality compliance is essential to ensure the accuracy and compliance of the results of preclinical studies and clinical trials of drugs under development, to ensure the quality of products, and to facility strict regulatory review and approval. At present, the company has a comprehensive quality management system, including analytical method development, quality control and quality assurance, covering the whole research and development process and product life cycle. The system has complete capabilities, including raw material management, raw material inspection and release, process control, drug release inspection, stability study and facility/equipment verification.
In addition, the quality management team also ensures the compliance of R&D, production and quality control, implements good manufacturing quality management standard (GMP), and facilitates the approval of drugs under development by regulatory authorities. The team also regularly inspects and audits the company's material suppliers and service providers. At the same time, the company hires external experts, including former Food and Drug Administration officials, to evaluate the company's quality management system and perform gap analysis based on international standards.