Kumhlaba wanamhlanje wehlabathi jikelele, ukuthunyelwa kwamanye amazwe amayeza kunye neemveliso zempilo ayisengomcimbi olula wokujikeleziswa kwempahla yorhwebo, kodwa ngumdlalo ontsonkothileyo obandakanya imigangatho yomgangatho, uthotyelo lolawulo, kunye nokuziqhelanisa nenkcubeko. Ukujongana neemarike zamazwe ngamazwe ezahlukeneyo ezifana ne-EU, i-US, uMbindi Mpuma, kunye ne-Indonesia, amashishini ahlala edibana nemiqobo ephezulu kakhulu yokungena. Nangona kunjalo, ngokuthembela phambili -ekubeni kwayo kwihlabathi jikelele kunye nolawulo olungqongqo lobulunga, iKornnacCaps yoyise ngempumelelo le miqobo, ibe liqabane eliqinileyo elifanele ukuthenjwa kwintsebenziswano yamazwe ngamazwe.
IMarike ye-EU: iNqanaba eliMabini lokuKhuselwa kokusiNgqongileyo kunye noKhuseleko
Iyaziwa ngemithetho engqongqo, imarike ye-EU ifuna eyona migangatho iphezulu. I-KornnacCaps ayigqibanga kuphela ukubhaliswa kwe-EU TRACE, iqinisekisa ukulandelelwa kwemveliso elubala, kodwa ikwafumene impumelelo ebalulekileyo yezobuchwepheshe. I-Ethylene Oxide yayo (EtO){2}}inkqubo yokuvala inzala yasimahla isusa iingozi ezinokubakho, iqinisekisa ukhuseleko lwamayeza; I-Titanium Dioxide {3}uyilo lwasimahla lulungelelaniswa neendlela zamva nje zolawulo lokhuseleko lokutya lwe-EU. Ixhaswa ziZatifikethi zoNyango lweMfuyo ezigunyazisiweyo, i-KornnacCaps inceda amaqabane ukuba awele ngokulula imiqobo yorhwebo eluhlaza ye-EU enenkangeleko esulungekileyo, ehambelana nokusingqongileyo, kunye neprofayili ethobelayo.
IMarike yase-US: Ufanelekele ngokupheleleyo uMthintelo{0}}uFikelelo olungaMahla
Njengeyona marike inkulu yoxubo-mayeza kwihlabathi, i-US ibeka imigangatho engqongqo yokuphononongwa kwe-FDA. I-KornnacCaps igqibe ngempumelelo ukufayila kwayo i-DMF (Drug Master File), ebonisa ukuba iinkqubo zayo zokuvelisa, ulawulo lomgangatho, kunye nezibonelelo zihambelana ngokupheleleyo nemimiselo yase-US. Kwiinkampani zamachiza ezifuna ukungena kwimarike yase-US, ukukhetha i-KornnacCaps kuthetha ukubhekisela ngokuthe ngqo kwifayile ye-DMF ekhulileyo, inciphisa kakhulu umjikelo wokuqaliswa kwemveliso ngelixa unciphisa iindleko zokuthotyelwa kunye nobungozi.
UMbindi Mpuma kunye ne-Indonesia: uQinisekiso lweHalal kunye neGenetic{0}}iNqanaba lokulandelelwa
Kwiimarike zeHalal, ukucoceka kwemathiriyeli ekrwada kumisela ngokuthe ngqo ukusebenza kwemveliso. I-KornnacCaps ilungisa ngokuchanekileyo iimfuno zenkolo nezenkcubeko zaseMbindi Mpuma nase-Indonesia. KuMbindi Mpuma, imathiriyeli yayo eluhlaza ithobela ngokupheleleyo imigangatho yeHalal. Kwi-Indonesia, ilizwe elinabona bantu baninzi bangamaSilamsi emhlabeni, iKornnacCaps ifumene isatifikethi seHalal esamkelwe ngokusemthethweni kwiwebhusayithi karhulumente wase-Indonesia. Okunyanzelisayo nangakumbi kukuba imveliso ilupasile uvavanyo lwe-DNA, iqinisekisa ngokucacileyo ukuba iqulethe kuphela i-bovine{4}}izithako eziphumayo kwaye ayinamalungu eehagu. Eli nqanaba lemfuza{6}}lokulandeleka lokucoceka akwanelisi nje kuphela iimfuno zezenkolo kodwa likwafumana ukuthenjwa ngokupheleleyo ngabaxumi.
Iqabane kunye neKornnacCaps, Phumelela kwihlabathi jikelele
Ukukhetha iKornnacCaps ayikuko nje ukukhetha umgangatho ophezulu wemveliso yecapsule engenanto; imalunga nokukhetha i-Fast Track ukuya kwimarike yehlabathi. Ukusuka kuthotyelo lolawulo eNtshona ukuya kuhlengahlengiso lwenkcubeko kuMbindi Mpuma nase-Indonesia, i-KornnacCaps isombulula eyona mingeni yesatifikethi kunye nemiba esemgangathweni kwinkqubo yokuthumela ngaphandle. Oku kuvumela amahlakani ukuba agxile kulwakhiwo lophawu kunye nokwandiswa kweemarike ngaphandle kokuxinwa ziinkqubo zokungena ezintsonkothileyo, ngokudibeneyo ukuvula isahluko esitsha kushishino lwezempilo lwehlabathi.
