Medicinal product safety

High expectations with regard to pharmacovigilance

In recent years the regulatory authorities have focused increasingly on safety issues. This means that you have to fulfil all expectations in terms of pharmacovigilance before you obtain marketing authorisations for your products. Upon receipt of marketing authorisation at the latest, you are confronted with a wide variety of tasks which place intense pressure on your time and human resources.

Focus on costs and benefits

Due to our many years of experience we know what really matters in the area of pharmacovigilance. As a result we can take care of your operational obligations as a marketing authorisation holder.

We analyse your structures

In the course of an on-site visit we ascertain which drug safety processes you have already established. At the end of our analysis we give you clear feedback about which processes are sustainable and which processes require modification.

Corrective and preventive action (CAPA)

We propose specific and practical measures designed to optimise and augment your existing system. At all times we focus on the available resources, patient safety and the relevant statutory provisions.

Process implementation, documentation, training

Together with your company we create those structures and processes that are necessary for a sustainable safety system, including the relevant documentation. We also provide intensive training to ensure that each member of your staff is in full command of his or her role.

Outsourcing of operational activities

Profit from the performance potential of our experienced team and capitalise on the recognised and validated structures that are in place at YES. Our services cover the following areas:

• Side effect management
• Periodic reporting
• Monitoring the risk-benefit profile of your medicinal products