At Pharmexon Consulting, we fully acknowledge the need to protect patient well-being and strictly adhere to all EU pharmacovigilance requirements. Pharmexon keeps pace with current trends, delivering high-quality, state-of-the-art services while also actively exploring the possibilities of automation and AI to enhance pharmacovigilance capabilities.
End-to-end pharmacovigilance systems during the entire life cycle of a product can be provided. The high scalability and versatility of Pharmexon‘s system enables specific needs to be met. This ensures straight-forward integration and compliance with regulatory requirements. Clients can rely on a robust fully functioning PV system run by experienced, highly competent PV specialists (medical doctors, pharmacists) and project managers.
Pharmexon specializes in the creation, provision, and management of the Pharmacovigilance System Master File (PSMF). This critical document is maintained up to date to ensure compliance with regulatory standards and facilitate inspection readiness.
With more than 20 years of experience in the pharmaceutical industry and local authorities, Pharmexon‘s EUQPPV offers expertise and oversight of PV activities, providing guidance to the PV team and acting as a contact person for the authorities on a 24/7 basis. Pharmexon‘s EUQPPV takes full responsibility for the client‘s products, ensuring patient safety.
Pharmexon‘s global literature monitoring service screens scientific literature worldwide to identify potential safety signals and individual case safety reports (ICSRs) related to the client‘s products. This proactive approach helps to stay ahead of potential issues, ensuring timely reporting of ICSRs, detection and mitigation of risks, maintaining the product information.
Expert management of the extended EudraVigilance Medicinal Product Dictionary (xEVMPD) is offered, ensuring that the client‘s product information is accurately and efficiently entered into the database. This service streamlines the client’s regulatory reporting processes, reducing administrative overhead and ensuring compliance with EMA requirements.
Pharmexon‘s quality and compliance management system ensure that the client‘s pharmacovigilance operations adhere to the highest standards of regulatory compliance and quality. Regular audits are conducted and participated in, implementing continuous improvement practices, safeguarding the products’ integrity and the organizational reputation.
Pharmexon provides and manages robust validated safety databases storing and analysing adverse event data securely and efficiently. The state-of-the-art databases support regulatory submissions and signal detection activities, ensuring that the tools needed to protect patient safety and comply with EU standards are provided.
+420 602 378 935
Pharmexon Consulting s.r.o
Štěpánská 65, Prague 1
11000 Prague, Czechia
