Guarantees the real-world vigilance of medicinal products, cosmetics, supplements, medical devices and cannabis-based products.
From isolated tasks to assembling the pharmacovigilance system, we guarantee the performance of these services while meeting the growing requirements of the industry.

Pharmacovigilance Systems

• Pharmacovigilance System Master File (PSMF);
• Operating procedures and work instructions;
• Maintenance of the quality management system that supports PhV activities.

Pharmacovigilance Activities

• Local and international literature monitoring;
• Adverse events and reactions management;
• PSUR & RMP elaboration;
• Medical review of adverse reactions;
• EudraVigilance monitoring;
• Signal Management;
• PhV training.

Qualified Person Responsible for Pharmacovigilance

• EU QPPV & Deputy;
• Local QPPV;
• Medical support.