From June27, 2022 to July 8, 2022, Dr Iris C. MacInnes carried out a remote inspectionon the Phase I Clinical Research Office of Haikou People's Hospital, theclinical unit that undertook the human bioequivalence (BE) test of voriconazoledry suspension, through the remote regulation assessment (RAA) mode. This BEstudy is used to support the China US dual reporting generic drug applicationsubmitted by Zhejiang Puli Pharmaceutical Co., Ltd. The two-week remoteinspection involved documents, records, electronic data, personnelqualifications, facilities and equipment management and other system relatedcontents. The inspectors highly appreciated the original records, programimplementation and test control of the clinical unit. Our company, as CRO,cooperated with the clinical unit and the sponsor to actively cooperate withthe inspection work. Finally, the project passed the remote inspection with nodefects.

This isthe first project that our company, as CRO, has accepted the remote inspectionof FDA clinical trial link after receiving international double reporting BA/BEservices. FDA is regarded as the most stringent and highest standard drugapproval agency in the world, and its management of BA/BE clinical trials isrecognized by means of post verification. This remote verification of the BEclinical part of voriconazole dry suspension passed smoothly with zero defects,indicating that our clinical operation department is formally in line withinternational standards, can undertake domestic and foreign BA/BE researchdouble reporting projects and provide high-quality technology outsourcingservices for global pharmaceutical customers.

Foundedin 2016, Zhejiang Longcharm Biomedical Technology Co., Ltd. is a technicalservice platform that provides professional clinical CRO services, third-partybiological analysis and testing, and innovative drug development andincubation. It has nearly 5000 square meters of offices and its ownlaboratories in Hangzhou Pharmaceutical Port and Phase IV of DazhouPharmaceutical Valley, fully supporting pharmaceutical enterprises' needs fordrug development projects in different stages from preclinical to commercial.

First meeting of voriconazole dry mixed FDA RRA                    Last meeting of voriconazole dry mixed FDA RRA