GVP-Compliant Safety Monitoring Systems
Full pharmacovigilance setup ensuring compliance with EAEU Good Pharmacovigilance Practice standards.
Robust safety monitoring and reporting systems designed to fulfill stringent local and regional pharmacovigilance obligations efficiently.
- check_circle Pharmacovigilance system support
- check_circle Regulatory PV documentation
- check_circle Qualified Person for Pharmacovigilance support
- check_circle Compliance consulting
Core Pharmacovigilance Offerings
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Local QPPV Services
Providing experienced Qualified Persons Responsible for Pharmacovigilance (QPPV) in EAEU
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PSMF & RMP Creation
Drafting and updating Pharmacovigilance System Master Files & Risk Management Plans
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Adverse Event & PSUR Reporting
Expedited ICSR reporting, periodic safety update reports & literature screening