Local PvOI Services

PVCON provides qualified Pharmacovigilance Officer of India (PvOI) services to ensure your organization meets all CDSCO regulatory requirements and PvPI (Pharmacovigilance Programme of India) obligations. Our PvOI professionals serve as your designated point of contact for Indian regulators on all drug safety matters, providing seamless coordination between your global PV operations and local compliance needs.

Our Local PvOI services encompass PSMF review and maintenance for the Indian market, PV compliance monitoring, safety reporting oversight, and regulatory coordination with CDSCO and PvPI authorities. We ensure that all Individual Case Safety Reports, aggregate reports, and signal management activities align with Indian regulatory timelines and requirements.

PVCON also supports organizations with inspection readiness preparation specific to CDSCO expectations, ensuring your documentation, processes, and personnel are prepared for regulatory scrutiny. Our experienced PvOI professionals integrate with your global PV framework while maintaining full compliance with local Indian pharmacovigilance regulations.