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Vigilances Turn-key solutions and services for Pharmacovigilance, Materiovigilance, Cosmetovigilance, Nutrivigilance and Toxicovigilance. VIGILANCES Read more Read more Compliance Ensure compliance with legislative, regulatory and administrative requirements. COMPLIANCE Read more Read more Medical writing Writing scientific and medical documents for healthcare professionals, authorities or the general public. MEDICAL WRITING Read more Read more

OUR EXPERTISE

Universal Medica is the preferred partner of healthcare stakeholders in the field of vigilance at local and global level. Our expertise extends to pharmacovigilance (Brand, generics, biosimilars), Materiovigilance, Cosmetovigilance, Nutrivigilance and Toxicovigilance, for parent companies or subsidiaries.

  • Spontaneous and solicited case management
  • Local and international literature watch (France, Europe, Africa, Asia)
  • EudraVigilance : L2A request, MLM request, XEVMPD, EU QPPV registration and Trusted Deputy.
  • Drafting of safety reports PSUR, PBRER, DSUR, ACO, periodic compassionate use 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/or Local Qualified Person for Pharmacovigilance (LQPPV)
  • 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

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