PV Quality Management System

PVCON helps pharmaceutical and biotechnology companies establish, enhance, or scale their Pharmacovigilance Quality Management Systems (PV QMS) in alignment with EU GVP Module I, FDA guidance, and ICH Q10 quality principles. We support organizations in building structured, inspection-ready PV quality frameworks that ensure consistent compliance and operational governance.

Our PV QMS services include development of organizational structures and role-specific job descriptions, creation of comprehensive SOPs and work instructions, establishment of quality policies and governance frameworks, and implementation of CAPA and deviation management systems designed for pharmacovigilance operations.

PVCON also prepares Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) to ensure compliant safety data exchange with partners, licensees, and distributors. Whether you are a startup building your first PV system or an established company scaling operations, we deliver tailored QMS solutions that grow with your organization.