What it is

Pharmacovigilance is an essential monitoring activity aimed at detecting, assessing, understanding, and preventing adverse effects associated with medicinal products and medical devices. Through this activity, pharmaceutical companies ensure a continuous and well-documented evaluation of the benefit–risk profile of their products.

It is a complex process that requires in-depth knowledge of current regulations at both local and European levels, as well as specific expertise in data analysis and management, and in the preparation of documentation to be submitted to national and international regulatory authorities.

Our strengths

➕ Timely and rigorous service, always aligned with the latest regulations
➕ Speed and accuracy in handling reports and preparing documentation
➕ Operational flexibility to meet different client needs
➕ Ongoing, qualified support ensuring high quality standards
➕ Continuous monitoring to ensure the safety and efficacy of pharmaceutical products

How we can help you

• Acting as QPPV / Local Contact Person / PVQA
• Preparation of periodic documentation:
  • Periodic Safety Update Reports (PSUR)
  • Risk Management Plans (RMP)
• Management of the pharmacovigilance system and Pharmacovigilance System Master File (PSMF)
• Signal detection
• Monitoring of national and international literature and regulatory websites
• Management of ICSRs (Individual Case Safety Reports)
• Entry and maintenance of the product dictionary (xEVMPD)
• Pharmacovigilance support in clinical trials

Areas of expertise

✅ Medicinal products
✅ Medical devices

Target clients

✅ Italian and international companies and agencies
✅ Companies and agencies holding foreign marketing authorizations (MAHs)