Custom development, registration application and safety assessment of drug substances, intermediates and impurities
(1) Laboratory development of new process, Chinese-style amplification, trial production verification and domestic and foreign registration application of drug substances;
(2) Secondary improvement of the existing process of drug substances: reduced cost and improved quality of drug products;
(3) Registration application and advisory services at home and abroad, including domestic and foreign registration information writing and audit, reply to supplement with new technical data;
(4) Safety risk assessment: Issue an assessment report according to safety and thermal risk assessment requirements and assist enterprises to complete thermal risk assessment related to safety assessment;
(5) Impurity study: synthesize the impurities required by custom customers or separate and identify impurities in drug substance intermediates, provide impurity synthesis records or separation records and structure identification reports, assist customers in analyzing the sources and destinations of impurities and formulate standards;
(6) Patent service:Assist customers to complete the patent writing, audit and reporting.