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