We provide experienced Qualified Persons for Pharmacovigilance and local contact persons who take accountability for your PV system and represent you before health authorities.
QPPV Services
Provision of a Qualified Person for Pharmacovigilance to ensure 24/7 compliance, regulatory authority liaison and expert oversight of your PV system in line with EMA, MHRA and global requirements.
Local Contact Person for PV
Appointment and management of local safety officers to fulfil country-specific pharmacovigilance obligations and maintain direct communication with local health authorities.
QPPV Backup & Continuity
Robust backup solutions to ensure uninterrupted QPPV coverage and business continuity, even during absences or transitions.
Regulatory Authority Liaison
Direct support for communication with regulatory agencies, including responses to queries, inspections and audits.
PV System Oversight
Comprehensive oversight of your pharmacovigilance system, including SOPs, compliance monitoring and risk management activities.
Documentation & Compliance
Preparation and maintenance of all required QPPV and local contact documentation, ensuring audit readiness and regulatory compliance.
Global & Local Coverage
Support for QPPV and local contact requirements across multiple countries and regions, ensuring seamless global compliance.
24/7 Availability
Round-the-clock availability of QPPV and local contact services to meet urgent regulatory and safety needs.
