PharmaVigil offers medical literature surveillance as part of our range of drug safety services. We have an experienced team to comprehensively manage your scientific literature screening requirements in a cost-effective manner.
We offer a cost-effective solution for managing your company products’ safety data and partnered with a European safety database service provider to take care of your company’s future needs for processing ICSRs.
PharmaVigil’s consultants and team members team has years of experience of developing periodic safety reports (PSUR/PBRER/PADER/ and DSUR) and Risk Management Plans (RMP) in a cost-effective way. Whether it is a single simple document for generic or well established products or complex PSURs/PBRER, we can 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