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National QPPV / LPPV Network

With its wide Local Safety Officers (LSOs) network, Biomapas can fulfill all and any local Marketing Authorisation Holder’s obligations in EU and non-EU countries and perform all local pharmacovigilance representation activities, including:
 
  • Appointment of Lead LSO and Deputy LSO for each country and their nomination to the local Competent Authority;
  • 24/7 availability, where required;
  • Weekly monitoring of locally published scientific and medical literature;
  • Local processing of Individual Case Safety Reports (ICSRs), including reporting to the local Competent Authority, where applicable;
  • National regulatory intelligence;
  • Local support in Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) handling;
  • Delivery of pharmacovigilance training to local Marketing Authorisation Holders personnel.

All PV System & QPPV Services

A complete system with QPPV at your disposal.

Pharmacovigilance System set-up

PSMF Development and Maintenance

RMP Development and Maintenance

EU-QPPV

EAEU-QPPV

National QPPV

Big Enough To Cover  All Your Needs. Small Enough To Care. 

Meeting timelines and milestones is critical to move your development program forward while keeping the goal in mind. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization.

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