Ondrej Sedlak's Contact Details

Ondrej Sedlak's Company Details

iVigee

, Prague, Czechia • 13 Employees
Pharmaceuticals

Trustworthy, Approachable Professionals, Enabling Innovation and Sustainable Solutions, these values are what we keep in mind daily.Founded in 2021 by seasoned professionals with over 75 years combined experience within regulatory agencies, pharma & biotech, and PV service providers.Our focus is providing the following levels of service to our clients:- Pharmacovigilance Process Optimization-- PV Business Optimization, Process Analysis, System Integration, System Design-- PV Partnership Management, Computer System Validation, PV Training, Regulatory Intelligence- Signal and Risk Management-- PV Data Science, Signal Detection & Validation, Support of Multidisciplinary signal management teams, Proposals for precautionary actions and signal evaluations, Signal Management Optimization- Global and Local QPPV Outsourcing-- EU QPPV, Global QPPV, Global QPPV, QPPV Mentoring-- Local QPPV/Contact Person Services in EU Countries & Global Countries-- QPPV Office Services, Reference Safety Information & Label Monitoring and Updates- Audits and Due Diligence Services-- Full PV System Audits, Gap Analysis, Audit Strategy Assistance, Targeted Audits, CAPA Development, Follow-Up and Resolution--Inspection Readiness Training, Mock inspection training, Assistance during inspections, Inspection response assistance with CAPAs & findings- PV Vendor Selection Guidance-- Pre-Qualification of PV Providers, Initial audits and stress tests, Strategic and tactical advice on vendor selection procedure