Regulatory & Government Affairs

We focus on product classification, market access, pricing and reimbursement under Law 4472/2017 and Law 5243/2025, promotion and advertising, data and market exclusivity, product recalls, inspection readiness, conformity assessment, CE marking, clinical trials under Regulation (EU) 536/2014 and supply, manufacturing and licensing agreements. We deliver regulatory strategy support including engagement with the National Organisation for Medicines (EOF), the National Organisation for Healthcare Services Provision (EOPYY), the Greek Ministry of Health, the European Medicines Agency, EMA Scientific Advice procedures, EU Joint Clinical Assessments under Regulation (EU) 2021/2282, and engagement with EFPIA, SFEE, EUCOPE and BIA. We support clients on regulatory consultations, public hearings, industry positioning before competent authorities and policy development at national and EU level. Our daily involvement in policy and rulemaking gives us early visibility on regulatory change before it formally enters into force.