Pharmacovigilance

InfoLex proposes full services in safety and efficacy:

• creation of pharmacovigilance system, risk management plan, periodical safety update reports (PSUR).
• creation master-file of PhV system, express-report, report safety and efficacy, performance of audit for verification of the efficacy of the system created.
• qualitative verification of separate reports and simple table listings, professional consultations (for risk management, determination of signals).
• we will act as (representatives) qualified persons responsible for pharmacovigilance (QPPV) on behalf of your company in local regulatory authorities an any time suitable for you.