Safety Database created by Pharmacovigilance experts.
PSMF & SDEAs preparation and maintenance.
Advice and support in the creation of the Quality System.
EU QPPV, Local QPPV & UK- QPPV.
Monitoring the risk-benefit balance of their product.
Preparation, submission, assessment and monitoring.
Management their current Extended EudraVigilance medicinal product…
Development and support in all your activities in EudraVigilance.
Management of individual suspected adverse reactions and events.