Regulatory Pharma Net Srl (RPN)

RPN’s end-to-end support :
 Feasibility Analysis for SME Status.
 Orphan Designation in EU: obtaining special status for orphan drugs.
 PRIME eligibility: benefitting from early, proactive support from EMA.
 CMC, Pre-clinical, Clinical Gap Analysis: comparing EU and FDA requirements.
 Landscape Assessment, EU Advisory Boards.
 Regulatory/HTA Scientific Advice: streamlining regulatory/HTA processes with expert advice.
 Marketing Authorization Application: defining successful strategies.
 Early Access feasibility: unlocking early access options in EU countries before regular market access.
 Centralized HTA Dossier (JCA) and Procedure: Navigate centralized HTA assessment efficiently.
 National HTA Dossier and Procedures:  individual Pricing & Reimbursement processes in EU countries.
 Coordinated Launch readiness strategy.