Provision of Qualified Person for Pharmacovigilance (QPPV) to ensure 24/7 compliance, regulatory authority liaison, and expert oversight of your pharmacovigilance system in line with EMA, FDA, and global requirements.
Appointment and management of local safety officers to fulfill country-specific pharmacovigilance obligations and maintain direct communication with local health authorities.
Robust backup solutions to ensure uninterrupted QPPV coverage and business continuity, even during absences or transitions.
Direct support for communication with regulatory agencies, including responses to queries, inspections, and audits.
Comprehensive oversight of your pharmacovigilance system, including SOPs, compliance monitoring, and risk management activities.
Preparation and maintenance of all required QPPV and local contact documentation, ensuring audit readiness and regulatory compliance.
Support for QPPV and local contact requirements across multiple countries and regions, ensuring seamless global compliance.
Round-the-clock availability of QPPV and local contact services to meet urgent regulatory and safety needs.