From single-product start-ups to global portfolios, our consultants help you build, run and continuously improve a compliant pharmacovigilance system across all your markets.
PV System Setup & Compliance
Establishing and validating end-to-end pharmacovigilance systems, including SOPs, process mapping and regulatory documentation to ensure global compliance from day one.
Regulatory Intelligence & Strategy
Strategic guidance on EMA, MHRA, FDA and other global PV regulations, including risk management, regulatory submissions and lifecycle planning for new and existing products.
PV Audits, Inspections & Readiness
Comprehensive support for regulatory audits and inspections, including gap analysis, mock audits, CAPA management and inspection readiness training.
QPPV & Local PV Representation
Provision of Qualified Person for Pharmacovigilance (QPPV) and local safety officers, ensuring 24/7 compliance, authority liaison and expert representation.
SDEA & PSMF Management
Drafting, negotiation and maintenance of Safety Data Exchange Agreements and the Pharmacovigilance System Master File for seamless partner collaboration.
Ongoing PV Operations
Full-spectrum support for case processing, literature surveillance, signal management, aggregate reporting and risk minimisation, tailored to your portfolio.
PV Training & SOP Development
Bespoke training programmes and SOP development to embed a culture of safety, compliance and operational excellence across your organisation.
