PSURs are pharmacovigilance documents aimed to update the benefit-risk balance of a medicinal product after its authorisation. These periodic assessments must include any new information on the safety profile of the product in order to identify new or emergent risks, potential shifts in the balance, and measures to be taken. Writing a PSUR can be challenging, as it requires a critical thorough analysis of large volumes of safety data. We strive to provide timely and compliant deliverables that help identify any potential safety signal.

