Our Pharmacovigilance service stands out for its comprehensive approach in the development and audit of Standard Operating Procedures (SOP) in both the clinical and post-marketing settings. We specialize in the creation of corporate policies to report adverse events (AE), ensuring regulatory compliance and consistency in risk management. Moreover, we are committed to establishing key performance indicators (KPI) and developing metrics to evaluate the effectiveness of our processes, thus ensuring adherence to Good Pharmacovigilance Practices (GVP) and the Product Safety Master Plan (PSMF).

On the other hand, we offer compliance monitoring and supplier oversight services, conducting reconciliations and gap assessments to identify areas for improvement in drug safety management. Additionally, we implement corrective and preventive actions (CAPA) and manage deviations to ensure quality and compliance with regulatory standards. We prepare our clients for audits and regulatory inspections, ensuring the consistency and comprehensiveness of documentation and processes. We also specialize in consulting on Risk Safety Information (RSI) in the Investigator’s Brochure (IB) or the Company Core Data Sheet (CCDS), ensuring that processes align with current standards and guidelines. We offer a wide range of Pharmacovigilance training, tailored to different professional profiles, from general organization staff to scientists or commercial staff, including refresher courses and basic concepts for new employees in Pharmacovigilance.