Development of a Pharmacovigilance System Master File and a Risk Management Plan acc. Good Pharmacovigilance Practices

Recent changes in legislation mandate the submission of a risk management plan together with the application for marketing authorization.

Based on your clinical and pre-clinical safety data we would generate a pharmacovigilance specification, i.e. a clear profile of your product’s safety aspects and - if required - management tools to control the potential risk.

We are experienced in routine pharmacovigilance activities and advanced to tools for drug safety surveillance, such as registries, and post authorization safety trials.

We would also support risk minimization programs such as specific education programs etc.