Billev Pharma East

Billev Pharma East is a Ljubljana regulatory consultancy serving pharmaceutical and medical device companies. Its device practice offers MDR and IVDR gap analysis and transition support, technical-file preparation, ISO 13485 quality systems, classification, risk management, notified body certification support, PRRC and authorised representative services, EUDAMED, vigilance and clinical evaluation. The wider firm combines regulatory affairs with medical writing, pharmacovigilance, quality and digital consultancy through a named expert team.