Working on CDMO for Macromolecular Target Drugs
Export of finished pharmaceutical products
·Relying on large-scale production capacity, providing products with both market competitiveness and efficient and stable supply guarantee; We provide registration support and can deliver a complete set of English CTD registration materials, fully supporting international market applications.
Local filling of raw liquid
·Output a complete set of SOP for product and testing analysis methods, along with technical data for stability research and transportation validation; Provide full process technical support for localized implementation, share international mainstream production equipment, provide guidance on filling production line operation and maintenance, and help customers achieve local filling production after importing raw materials.
Transfer of formulation technology
·Complete delivery of product prescription process, formulation process specifications, and key consumables list; Synchronize the output of a complete set of process program files, operating SOPs, filter sterilization and filtration validation reports, quality standards for raw liquid products and finished formulations, and a complete set of analysis methods to achieve the complete transfer of process technology from raw liquid to formulation.