Pharmacovigilance

On local level we can support you in Hungary and through our network in Slovakia, Romania and Serbia also. We also have experience on supporting pharmacovigilance procedure on European level.

We have client from Small and Medium Enterprises to Big Pharma.

Please fell free to contact us in case of single support project or maintaining full pharmacovigilance system.

Our profile:

European level:

- EU-QPPV services
- Pharmacovigilance System development and maintenance
- Signal management and detection
- ICSR processing and entry to pharmacovigilance databases (EudraVigilance, Argus, Local)
- PV clause and agreement handling
- Development and maintenance of Risk Minimisation Plan
- Global and local training management
- Periodic Update Safety Report writing and submission
- Audit and Inspection management
- CAPA management

Local level:

- Local-QPPV, LSO representation
- Local ICSR collecting and processing
- SOP development and maintenance
- Local literature monitoring
- Quality check; Risk communication
- Local training plan and training
- Local aRMM implementation plan and distribution

Pharmacovigilance

Our profile:

European level:

Local level:

Our services

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