Adherence to stringent pharmacovigilance requirements is paramount for safeguarding patient well-being and ensuring the ongoing safety profile of pharmaceutical products. Our dedicated pharmacovigilance team provides comprehensive management and continuous monitoring of all safety aspects associated with your product lifecycle. Our extensive service portfolio includes:

• Pharmacovigilance (PV) System Design and Management: We develop and manage robust PV systems tailored to your specific needs, complemented by comprehensive PV training programs to ensure organizational expertise.
• Qualified Person for Pharmacovigilance (QPPV) Services: Provision of both EU QPPV services and Local QPPV services specifically for Croatia, ensuring local and regional regulatory compliance.
• Independent PV Audits: Conduct of thorough PV audits, available both on-site and remotely, to assess the effectiveness and compliance of your pharmacovigilance system.
• Post-Marketing Safety Management: Comprehensive post-marketing case processing management, encompassing adverse event collection, assessment, and reporting, alongside proactive signal detection and management activities.
  EudraVigilance Reporting: Timely and accurate electronic submission of Individual Case Safety Reports (ICSRs) and other relevant pharmacovigilance data to the EudraVigilance database.
• XEVMPD Database Management: Efficient entry and maintenance of detailed medicinal product information within the Extented EudraVigilance Medicinal Product Dictionary (XEVMPD).
• Global and Local Literature Review: Systematic screening of both global and local scientific literature to identify potential safety signals and emerging risks associated with your products.
• Risk Minimization Strategies: Development and management of risk minimization measures, including the creation and dissemination of Direct Healthcare Professional Communication (DHCP) letters.
• Pharmacovigilance in Clinical Trials: Comprehensive PV support throughout clinical development, including the preparation of Development Safety Update Reports (DSURs) and efficient case processing of adverse events occurring in clinical trials.
• Safety Data Exchange Agreements (SDEAs): Provision of expert assistance in the preparation and management of Safety Data Exchange Agreements with partners and stakeholders.
• Pharmacovigilance in Patient Support Programs (PSPs): Integration of pharmacovigilance activities within Patient Support Programs to ensure the safety of patients participating in these initiatives.
• Medical Device Vigilance: Expertise in managing vigilance activities for medical devices, ensuring compliance with relevant regulations and proactive safety monitoring.