Preparation of pharmacovigilance documents utilises an ever increasing proportion of company resources, particularly in light of the recent introduction of the DSUR and the imminent changes in pharmacovigilance legislation that will impact PSUR content and structure. Acadustri offers the following bespoke consulting service to pharmacovigilance departments, to ensure compliance, quality and efficiency:
Complete annual scheduling of PSURs, PSUR Addendums and Summary Bridging Reports to ensure compliance
Rationalisation of pharmacovigilance medical writing processes to improve quality and efficiency
Template development and refinement for all pharmacovigilance documents
Tailored trouble shooting to resolve issues impacting pharmacovigilance medical writing processes