Pharmacovigilance
We feature a complete pharmacovigilance service.
Safety throughout the product lifecycle.
From isolated tasks to assembling the pharmacovigilance system, we guarantee the performance of these services while meeting the growing requirements of the industry.
We also offer tailored solutions, when only specific activities are required.
OUR SERVICES INCLUDE
PhV Systems
PhV System Master File (PSMF)
SOPs and work instructions
Maintenance of the quality management system that supports PV activities
PhV Activities
RMP and PSUR writing
Management of adverse events and reactions
Medical review of adverse reactions
EudraVigilance monitoring
Signal Management
PV training
PV Audits
Qualified person responsible for PhV
EU QPPV
Local QPPV
QPPV Deputy
Medical Support