Pharmacovigilance & QPPV Services
Patient safety is at the heart of pharmaceutical operations, and robust pharmacovigilance systems are essential to meeting legal obligations and maintaining trust. Our Pharmacovigilance services ensure that every adverse event is monitored, assessed, and reported efficiently, protecting patients and enabling Marketing Authorisation Holders to maintain compliance.
We offer full-scale system setup and management, including training for client personnel, and our in-house Qualified Persons for Pharmacovigilance (QPPVs) provide oversight across the UK and EU. This ensures consistent monitoring of safety data, implementation of risk minimisation measures, and maintenance of a high standard of patient care.
Our services cover the handling and reporting of Individual Safety Case Reports, literature monitoring, preparation of Periodic Safety Update Reports, and signal detection. We maintain up-to-date product information, including SmPCs, leaflets, and labelling, and manage technical agreements and safety data exchange agreements to maintain compliance with regulatory standards.
Auditing existing systems and assisting during regulatory inspections is another critical aspect of our service. We liaise directly with competent authorities to address queries and ensure that safety monitoring processes are robust and auditable, giving clients peace of mind.
Whether managing one product or multiple lines with high case volumes, our flexible, scalable approach ensures that every Marketing Authorisation Holder meets their obligations while prioritising patient safety and regulatory compliance.
Ready to bring your products to market with confidence? Get in touch today.
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