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Safety evaluation reports (PSURs/ PBRERs/ RMPs/ CES)

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

How we do it?


Listen to You

Understanding your needs, your objectives and your restrictions are key elements to tailor made solution we will provide you with

Shape the Project Team

Once we have a clear view of the services required, we will allocate the right experts and a dedicated project manager to ensure a lean and efficient collaboration

Deliver high quality compliance

Our focus on quality, combined with the in-depth expertise of our specialists are the pillars for our long-term strategy to ensure your high standards are met and maintained


Specialist Support Outsourcing