MAHs without a PV department
Needing pharmacovigilance support without building a full team.
Pharmacovigilance · Benelux
Pharmacovigilance services for the Benelux
Pharmacovigilance outsourcing: local contact person, safety reporting, signal management and support for your pharmacovigilance system across Belgium, the Netherlands and Luxembourg.
How we support you
- Local contact person for pharmacovigilance in Belgium, the Netherlands and Luxembourg
- Support for your pharmacovigilance system and processes
- Guidance on local reporting obligations and contact with FAMHP, CBG-MEB and Luxembourg authorities
- Safety reporting: adverse events (ICSRs), PSURs and EudraVigilance follow-up
- Signal management and risk management plans (RMP)
- Setting up and maintaining the Pharmacovigilance System Master File (PSMF)
- Pharmacovigilance audits, inspection readiness and safety data exchange agreements (SDEA)
Pharmacovigilance in Benelux practice
Beyond the European GVP guidelines, FAMHP, CBG-MEB and the Luxembourg authorities expect a local contact point and local follow-up. We take on that role and keep your safety system inspection-ready.
Who we work for
International companies
Placing pharmacovigilance for the Benelux with a local partner.
Companies in transition
Acquiring products, implementing a new PV system or facing an announced inspection.
How we work together
1. Exploration
We discuss your portfolio, current PV system and obligations.
2. Concrete proposal
You receive a clear proposal with scope, roles and planning.
3. Execution
An experienced PV professional takes on the tasks and reports to you.
Ready to discuss a compliance project or need?
Tell us where your team needs support. We will contact you personally.