Efficient and cost-effective End to End ICSR management for the life sciences industry including cell and gene therapy and cosmetics. Strong QMS coupled with regulatory intelligence ensures delivering quality reports across the globe.

Comprehensive Literature surveillance ranging from designing search strings to annotation, FTA procurement and translation. We support global local literature, ongoing safety, literature for ICSR, aggregate and signal reports governed by stringent KPIs.

Team of experienced physicians engaged in medical triage, review of ICSRs / SAEs / SUSARs, aggregate reports, AoSEs, clinical trial safety data and signal management and provide medical oversight to the overall engagement.

Our highly experienced team of physicians and HCPs manage specialized surveillance including signal management, authoring and review of RMPs, REMS support and communication with regulatory agencies.

Our entire spectrum of QPPV services include QPPV, deputy QPPV, Local Responsible Person for PV who provide oversight to your PV processes, involve in regulatory communications, support SDEA review, dossier submissions (PSMF, RMPs etc.)