Turi ishyirahamwe rikora amasezerano (CMO) muri Chimie na Biotechnology

Ishirahamwe rikora amasezerano (CMO), rimwe na rimwe ryitwa ishyirahamwe rishinzwe iterambere n’inganda (CDMO), ni isosiyete ikorera andi masosiyete mu nganda z’imiti hashingiwe ku masezerano yo gutanga serivisi zuzuye ziva mu iterambere ry’ibiyobyabwenge binyuze mu gukora ibiyobyabwenge.Ibi bituma ibigo bikomeye bikorerwamo ibya farumasi bitanga ibyo bice byubucuruzi, bushobora gufasha mubunini cyangwa bushobora kwemerera uruganda runini kwibanda kubuvumbuzi no gucuruza ibiyobyabwenge aho.

Serivisi zitangwa na CMO zirimo, ariko ntizigarukira gusa: kubanziriza-gutegura, guteza imbere formulaire, ubushakashatsi buhamye, iterambere ryuburyo, ibikoresho byo kwipimisha mbere yubuvuzi nicyiciro cya mbere, ibikoresho byikigereranyo byamavuriro, gutuza kumugaragaro, kwaguka, kwiyandikisha ibyiciro n'umusaruro w'ubucuruzi.CMO ni abakora amasezerano, ariko nabo barashobora kuba ibirenze ibyo kubera iterambere.

Kwiyegurira CMO yemerera umukiriya wa farumasi kwagura ibikoresho bya tekiniki atiyongereye hejuru.Umukiriya arashobora noneho gucunga umutungo wimbere nigiciro yibanda kubushobozi bwibanze nimishinga ifite agaciro kanini mugihe agabanya cyangwa atongeyeho ibikorwa remezo cyangwa abakozi ba tekinike.Uruganda rukora imiti rwihariye kandi rwihariye rukwiranye cyane nubufatanye bwa CDMO, kandi ibigo binini bikorerwamo ibya farumasi bitangiye kubona umubano na CDMO nkibikorwa aho kuba amayeri.Hamwe na bibiri bya gatatu byinganda zimiti zitangwa hanze, kandi abatanga ibyifuzo bahabwa umugabane wintare, ibyifuzo byinyongera birashyirwa mubice byihariye, ni ukuvuga dosiye yihariye.

Gushyira mu bikorwa umushinga

I. CDMO yubatswe kugirango ikorere abakiriya bombi iterambere & ubucuruzi

II.Igurisha ryibanze ku mibanire yubucuruzi

III.Imicungire yimishinga yibanze ku iterambere ryiza & ihererekanyabubasha

IV.Kwimura neza kuva murwego rwiterambere ujya mubucuruzi

V. Serivise z'abakiriya / Urunigi rwo gutanga rwibanze ku isoko ry'ubucuruzi

Turi ishyirahamwe ryubushakashatsi bwamasezerano (CRO) mubikorwa bya farumasi nubuhanga bwibinyabuzima

Ishirahamwe ryubushakashatsi bwamasezerano, ryitwa kandi Clinical Research Organisation (CRO) nishirahamwe rya serivise ritanga infashanyo muruganda rwa farumasi na biotechnologie muburyo bwa serivisi zubushakashatsi bwa farumasi zitangwa hanze (kubiyobyabwenge nibikoresho byubuvuzi).CROs kuva mumiryango minini, mpuzamahanga yuzuye yuzuye kugeza mumatsinda mato, niche yihariye kandi irashobora guha abakiriya babo uburambe bwo kwimura ibiyobyabwenge cyangwa igikoresho gishya kuva cyatangiye kugera kubucuruzi bwa FDA nta muterankunga wibiyobyabwenge ugomba gukomeza abakozi kuriyi serivisi.

LEAPChem itanga umurongo umwe, hamwe nibisubizo byinshi mubisubizo byabigenewe, bishyigikiwe na serivisi zisesengura isi.Igisubizo kirihuta, gifite umutekano kandi cyiza-kinini.Yaba itezimbere inzira nshya cyangwa itezimbere inzira isanzwe, LEAPChem irashobora kugira ingaruka mubice bikurikira:

I. Kugabanya umubare wintambwe yubukorikori hamwe nigiciro

II.Kongera imikorere neza, gutanga umusaruro no kwinjiza

III.Gusimbuza imiti mibi cyangwa ibidukikije bidakwiye

IV.Gukorana na molekile zigoye hamwe nintambwe nyinshi

V. Gutezimbere no gutezimbere inzira zihari kugirango habeho synthes nziza nziza mubikorwa byubucuruzi