Pharmacons offers support in monitoring the lifecycle of companies’ products and safeguard their benefit/risk profile through periodic safety reports and risk management plans, to ensure that safe and effective medicines are delivered to patients worldwide. Our experts have an in-depth knowledge of both the technical and regulatory aspects and they can assist you with the preparation of necessary safety documents, scientifically based documents where the amount of information provided is proportionate to the risk, to optimize the continued safe use of the medicinal products.

Our services:

• Preparing periodic benefit-risk evaluation reports (PBRER) and other aggregate reports (non-EU PSURs, ACOs)
• Writing RMPs and RMP maintenance in line with GVP requirements
• Strategic consulting in designing risk minimization programs to meet regulatory requirements
• Advise or perform analysis of the effectiveness of the risk minimisation activities
• Preparing Clinical Expert Statements
• Risk-Benefit Assessment
• CCSIs preparation and maintenance
• Responses to authority requests