Establishing and validating end-to-end pharmacovigilance systems, including SOPs, process mapping, and regulatory documentation to ensure global compliance from day one.
Strategic guidance on EMA, FDA, CDSCO, and other global PV regulations, including risk management, regulatory submissions, and lifecycle planning for new and existing products.
Comprehensive support for regulatory audits and inspections, including gap analysis, mock audits, CAPA management, and inspection readiness training.
Provision of Qualified Person for Pharmacovigilance (QPPV) and local safety officers, ensuring 24/7 compliance, authority liaison, and expert representation in India and globally.
Drafting, negotiation, and maintenance of Safety Data Exchange Agreements (SDEA) and Pharmacovigilance System Master File (PSMF) for seamless partner collaboration and regulatory alignment.
Full-spectrum support for case processing, literature surveillance, signal management, aggregate reporting, and risk minimization activities, tailored to your portfolio and markets.
Bespoke training programs and SOP development to embed a culture of safety, compliance, and operational excellence across your organization.