We run outsourced pharmacovigilance for MAHs and CROs. We also build the software behind it.
Five stages. One accountable team. Select a stage to see what we do.
Reports arrive from many sources. We receive, log and process each one into a structured case.
Drug safety operations and the technology behind them, from one team.
Outsourced pharmacovigilance and quality operations for MAHs and CROs.
Custom software and digital transformation, built to production standards.
Reporting timelines are fixed, and inspectors expect every case to be traceable.
Processes built against GVP and ICH guidelines, with documented case handling from intake to submission.
Our own PV team works in IntelliBase every day.
We state what we can support, and nothing more.
Built against GVP, ICH, EMA, FDA and EDA guidelines from the start.
The team behind our software also hardens the systems we deliver.
Case data, signals and submissions are handled with traceable records.
A regional base, with operating standards set for multinational clients.
years of pharmacovigilance experience across our team.
Our own PV team works in IntelliBase. We use what we sell.
Tell us your case volume, markets and timelines. We will outline how we would run it.
Request a consultationOutsourced PV support: Start with a scoping call.A short conversation to understand your PV or technology needs.
