R&D center

Registration and sales agent in international market 

Now, we can offer agency service to help customers make declaration and registration of chemical APIs, preparation and chemical intermediates, related technical service and market cooperation in the foreign markets (FDA, EU, India and other developing markets). We have an experienced, efficient, well-organized and rigorous work team for the drug registration in international market, and they are familiar with relative registration laws, regulations and declaration procedures. With years’ experiences in the registration, renew and maintenance of DMF, EDMF, COS, we are very good at CGMP management: we have the good ability to establish related CGMP systems which are strictly in accordance with the regulations, laws and guidance of FDA, EU and ICH for APIs; we help carrying out all kinds of authentication works and give instructions to relative departments to manage quality-involved problems according to international standards.  Now, we can offer all fields of technical supports and services, including the assembly of CTD-format documents, compiling, translation, submit, renewing, maintenance, the establishment of CGMP system (including the checks of all equipment, facilities, methods and techniques), daily operation and route maintenance.

At present, one of our products have got DMF number successfully, and there will be 2 or 3 products can get DMF numbers soon. Moreover, we are very experienced on the field audit and help several factories passing the audits of foreign customers. We also establish close communicating and cooperative relationships with several famous companies in the world. Taking the experiences of famous enterprises on quality management as reference, we are working hard to improve and promote management system continuously. Closely following the developing trend of pharmaceutical industry, we are working hard to improve cooperating relationships with our business partners all around the world.