PSURs are considered important pharmacovigilance documents by the authorities a. A PSUR in pharmacovigilance that fails to examine and critically review the safety of the product often leads to punitive demands from regulators for additional time- and resource-intensive cumulative analyses.
The regulations PSUR Pharmacovigilance are complex, and effective timetabling for multiple products can be difficult and lead to costly duplication of effort.
Pharmavigil consultants and staff have years of experience of planning and writing periodic safety update reports, PADERs and DSURs to meet the need.
System establishment, PV-QMS & procedural development activities
Safety data collection, evaluation, understanding and prevention of ADRs/AEs
Development & submission of periodic safety writing reports
Global/Local Literature searching followed by classification
Queries (Call/Email) Receipt & Resolution Management
PharmaVigil is equipped with fully supported and regulatory compliant safety database solutions.
Quality and Compliance are highest priorities for us while handling drug safety and other activities.
Development & submission of PSMF/PSSF, PvMF & PSMF summary as part of module 1.8.2
RMP/REMS Risk identification followed by development of plan