GMP in QP

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

GMP in QP

PONUJAMO VAM

  • Certificiranje serij za sprostitev zdravil v promet, ki jih izvaja odgovorna oseba za sproščanje posameznih serij
  • Podporo pri upravnih postopkih, v okviru pridobitve dovoljenja za proizvodnjo zdravil / zdravilnih učinkovin
  • Regulatorno podporo med inšpekcijskimi nadzori s strani pristojnih organov
  • Certificiranje serij zdravil za klinična (IMP) in bioekvivalenčna (BE) preizkušanja v skladu z načeli in smernicami dobrih praks
  • Zunanje presoje proizvajalcev zdravilnih učinkovin in zdravil v skladu z načeli in smernicami dobre proizvodne prakse
  • Svetovanje na področju implementacije zahtev smernic o dobri proizvodni praksi v sistem vodenja kakovosti podjetja
  • Začetno in redno usposabljanje osebja
  • Odgovorno osebo za sproščanje posameznih serij, ki jo je ODOBRIL pristojni organ za zdravila in medicinske pripomočke

QP - Odgovorno osebo, ki jo je ODOBRIL pristojni organ

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
medicine

I think it is quite remarkable how we as humans have improved in the pharmaceutical and medical fields in the last 100 years. I am sure that we will remain courageous and continue to innovate!

Martina

Božíková

MASTER'S in PHARMACY REGULATORY AFFAIRS & PHARMACOVIGILANCE OFFICER