SERVICE

The PV consulting service has been started using the GxP-compatible validation method of Pharmacovigilance System with AI functions

Providing consulting services to develop RFIs and RFPs for single global safety systems

Suggestions to improve safety adverse event case data entry/evaluation and regulatory reporting

Provision of safety regulatory information by
regulatory authorities in Japan, the United States, Europe, and Asia

Providing training sessions on ICH E2B (R2)/(R3) guidelines

Support for UAT (User Acceptance Test) scripting and execution

SAP ERP System (S4/HANA, Solution Meager, MDG) GxP CSV
compliant

Support for PMDA EDI/GW connection testing (when renewing Digital Certificates)Support for PMDA EDI/GW connection testing