I-CRO&CDMO

Inkundla ephelele isisunguliwe ukuze kuhlinzekwe ngezinsizakalo ze-CRO ne-CDMO ngamathimba e-R&D anamakhono aphezulu avela kozakwethu.

Izinsizakalo ezijwayelekile ze-CRO zihlanganisa ukuthuthukiswa kwenqubo, ukulungiswa kanye nokuhlukaniswa kwamazinga angaphakathi endlini, isifundo sokungcola, ukuhlukaniswa nokuhlonza ukungcola okwaziwayo nokungaziwa, ukuthuthukiswa kwendlela yokuhlaziya nokuqinisekisa, isifundo sokuzinza, i-DMF nokusekelwa ngokomthetho, njll.

Izinsizakalo ezijwayelekile ze-CDMO zifaka ukuhlanganiswa kwe-peptide API kanye nokuthuthukiswa kwenqubo yokuhlanza, ukuthuthukiswa kwefomu lomthamo wokuqeda, ukulungiswa okujwayelekile kwereferensi kanye nokufaneleka, ukungcola kanye nokuhlaziywa kwekhwalithi yomkhiqizo, uhlelo lwe-GMP oluhlangana ne-EU kanye ne-FDA ejwayelekile, ukwesekwa kwamazwe ngamazwe kanye ne-dossier, njll.