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Izkušnje

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Klinična preskušanja – dosežki

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Clinres Farmacija razpolaga z znanjem in sredstvi, ki ji omogočajo uspešno izvajanje najrazličnejših projektov – od manjših lokalnih kliničnih preskušanj do zahtevnih, večsponzorskih in mednarodnih programov.

Strokovno znanje na ključnih področjih:

   onkologija,

   endokrinologija in presnova,

   kardiologija

Izkušnje na specifičnih in redkih področjih:

   pljučna hipertenzija pri novorojenčkih,

   kronična limfocitna levkemija,

   kronični hepatitis C,

   nova zdravljenja spinalne mišične atrofije (SMA) pri otrocih in odraslih.

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Globalne PV storitve:

   EU QPPV

   razvoj in vzdrževanje sistema farmakovigilance in glavnega dosjeja o sistemu farmakovigilance (PSMF),

   spremljanje globalne literature.

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Lokalne PV storitve:

   lokalna oseba za PV,

   strokovno svetovanje o lokalnih PV zahtevah,

   razvoj in vzdrževanje sistema farmakovigilance,

   spremljanje lokalne literature.

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Farmakovigilanca

Ponujamo globalne in lokalne storitve farmakovigilance.
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Regulatorne zadeve

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Naši strokovnjaki imajo bogate izkušnje s področja regulatornih zadev in so odlično usposobljeni za komunikacijo s pristojnimi organi.

Naše storitve so:

   kakovostne,

   skladne z veljavno zakonodajo in predpisi,

   izvedene pravočasno.

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Storitve, ki jih nudimo:

   podpora pred izdajo dovoljenja za promet z zdravilom,

   predložitev vloge za pridobitev dovoljenja za promet,

   mnenja izvedencev,

   dokumentacija v elektronski obliki (eCTD),

   vzdrževanje dovoljenj za promet,

   vloge za določitev cen in

   svetovanje

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Storitve nudimo za:

   zdravila (CP, DCP, MRP, NP)

   zdravila za uporabo v veterinarski medicini (CP, DCP, MRP, NP),

   medicinske pripomočke,

   prehranska dopolnila,

   kozmetiko in

   biocide

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Preverite vse storitve, ki jih ponujamo

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