Eight stages. Zero exceptions. Every case.
A European specialty pharma company receives GCC marketing authorisation and needs a compliant local PV system operational within 90 days. We establish their case intake process, local authority reporting protocols, and provide a dedicated ICSR processing team.
A mid-size Nordic biotech faces a product recall that generates several hundred spontaneous reports in a compressed window. We deploy a scaled processing team alongside existing PV staff to eliminate backlog without compromising case quality or reporting timelines.
Our team conducts a mock inspection against GVP Module VI criteria, reviewing case files, identifying documentation gaps, and preparing response documentation. We have seen the patterns inspectors focus on — and know where underprepared PV systems typically fail.
As a company's product portfolio expands, signal detection complexity and literature monitoring scope increase proportionally. We scale the PV team by therapy area expertise, adding oncology or rare disease specialists as the portfolio evolves.
Every case. Every deadline.
A missed 15-day expedited report is not a process failure — it is a compliance failure with measurable regulatory consequence.
Whether you are managing a compliance backlog, preparing for first authorisation, or scaling a growing portfolio — we can design a PV operation around your specific situation.