From PSUR to Pharmacovigilance plan

The professionals of Zwiers Regulatory Consultancy have the experience and skills to perform many pharmacovigilance activities. We can support:

• Periodic reporting of the safety profile of a drug in development or on the market (ASR/DSUR/PSUR)
• Writing of narratives for selected post-marketing cases 
• Risk management plans required as part of the marketing authorization application and aimed to pro-actively identify safety risk and to describe how to address and reduce these
• Pharmacovigilance data analysis to address a specific health authority request or question
• Product specific signaling by case processing and expedited and periodic reporting to identify trends or safety issues that may alter the benefit-risk ratio of a product
• Literature screening for case or study reports to ascertain that any changes to or relevant information on a product's safety profile are detected and reported
• Spontaneous report assessment, evaluation and interpretation

If you like our help with any of the above, please contact us.