Practice areas

Expertise

Pharegis regulatory work is organised around six connected practice areas.

Each combines strategic assessment with practical execution across market entry, approval and lifecycle continuity.

EAEU medicinal product registration, API registration in Russia, dossier harmonisation, variations and lifecycle management.

EAEU GMP certification, inspection readiness, documentation control, CAPA and authority expectations.

Registration, technical documentation, clinical evidence and certification questions.

Clinical and preclinical evidence programmes supporting medicinal product registration.

EAEU pharmacovigilance systems, PSMF and RMP governance, local vendors and sponsor oversight.

Regulatory pathway assessment, gap analysis, strategy and decision-ready planning.