Home TO SERVE
THE WELLNESS
OF THE
PATIENTS
Our expertise Our expertise
Information médicale Handling products enquiries from healthcare professionals and patients. MEDICAL
INFORMATION
Our expertise Our expertise
Vigilances Record and report on cases of Pharmacovigilance, Materiovigilance, Cosmetovigilance, Nutrivigilanceand Toxicovigilance. VIGILANCES Read more Read more Compliance Ensure compliance with legislative, regulatory and administrative requirements. COMPLIANCE Read more Read more

OUR EXPERTISE

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.

Vigilance Academy

A complete training modules for healthcare professionals in vigilance management: pharmacovigilance, Materiovigilance , Cosmetovigilance , Nutrivigilance

News

Previous
Next