Services

Regulatory Consultancy

Regulatory Affairs & Strategy

Dossier development and Due Diligence

Product Lifecycle Management

MRP/DCP Preparation

Pre-submission Meetings

Health Economics and Outcome Research

Cost-effectiveness and budget impact modeling

Cost-effectiveness analysis alongside clinical trials

Dossier preparation for Health Technology Assessment (HTA) submissions

Go/no-go models to inform internal decision-making

Preference elicitation studies (e.g. discrete choice experiments, time trade-off or standard gamble)

Real World Evidence

Pharmacovigilance

24/7 intake of adverse event cases by medical information specialists

Medical literature searches to identify and process reportable cases

Risk management and Risk minimization plans

Provision of EU QPPV and Deputy EU QPPV services

PSMF lifecycle management

EudraVigilance and Article 57 (XEVMPD) regulatory management