Your Trusted Pharmacovigilance Partner
Personalized pharmacovigilance solutions ensuring compliance and managing safety risks effectively for your business.
Our services
Here are some of the PV services we can offer you.
Vendor Management & Regulatory Compliance
We provide strategic oversight of pharmacovigilance systems and third-party vendor activities to ensure compliance with global regulatory requirements. Our services include pharmacovigilance system design, SDEA creation and negotiation, vendor audits, deviation/CAPA management, inspection readiness, and PVQMS support tailored to your operational model.
Post Market Surveillance (PMS)
We support all aspects of post-market surveillance, from ICSR processing to signal detection and benefit-risk evaluation. Our expertise includes PSUR and RMP authoring, risk minimisation measures (aRMM), literature screening, safety variation support, and local UK PV affiliate compliance, ensuring your products remain safe and compliant throughout their lifecycle.
We offer pharmacovigilance support for investigational products throughout clinical development. Our services include safety data review, DSUR authoring, protocol safety input, IB and ICF review, and oversight of CRO PV activities to ensure trial compliance with GCP and regulatory requirements.