Vigilance

InfarAMA is your perfect choice for the implementation of a complete pharmacovigilance system for your company: infarAMA can act as European Qualified Person for Pharmacovigilance (EU QPPV) and/or as Local Contact Person for Pharmacovigilance (LCP PV), with access to Eudravigilance, medical evaluation.

Alternatively infarAMA can offer you a tailor-made solution for your company (e.g.: responsible for parts of the pharmacovigilance system or act as the Deputy EU QPPV or Deputy of the LCP PV).

These services help you to fulfil European and national pharmacovigilance requirements without having to add additional capacities while guaranteeing EU QPPV and LCP PV availability as required.

In addition, infarAMA can help medical device manufacturers and distributors to ensure they meet the requirements of the materiovigilance legislation by establishing a medical device vigilance system and by acting as Qualified Person for Materiovigilance (QP MV) and/or as Local Point of Contact for Materiovigilance (LPC MV).