Universal Medica is the preferred partner of healthcare stakeholders in the field of vigilance. Our expertise extends to pharmacovigilance (Brand, generics, biosimilars), Materiovigilance, Cosmetovigilance, Nutrivigilanceand Toxicovigilance, for parent companies or subsidiaries at local and international level.
- Spontaneous and Solicited Case Management
- Local and international bibliographic watch
- EudraVigilance : L2A request, MLM request, XEVMPD, EU QPPV registration and Trusted Deputy.
- Drafting of safety reports PSUR, PBRER, DSUR, ACO, periodic ATU/RTU reports and responses to requests from authorities
- Benefit/risk management: signal detection and management, risk management: drafting RMPs, implementation of Risk Reduction Plans and safety communication.
- Delegation of European Qualified Person for Pharmacovigilance (EU QPPV) and Local Person for Pharmacovigilance (LPPV)
- Quality system in pharmacovigilance: support for audits and inspection, drafting and monitoring of PSMF, SDEA, procedures and training.
A complete training modules for healthcare professionals in vigilance management: pharmacovigilance, Materiovigilance , Cosmetovigilance , Nutrivigilance