PV Regulatory Intelligence
Insuvia provides PV Regulatory Intelligence services and ensures that our clients maintain compliance with the latest regulatory requirements and guidelines. We provide central oversight of regional/global requirements (EMA, ICH, etc.) as well as utilize our Local PV infrastructure and LPPVs (Local Persons for Pharmacovigilance) to gather local PV regulatory intelligence from National Competent Authorities.
We promptly communicate PV regulatory Intelligence updates to clients, providing a summary, an impact assessment and any necessary actions. Our PV regulatory intelligence service can be tailored to the clients’ needs in terms of territories, content, frequency and other aspects.
PV Regulatory Intelligence on new PV requirements, changes, and developments to watch
Regional Pharmacovigilance Regulatory Intelligence (EMA, MHRA, FDA, ICH, WHO, etc.)
Local Regulatory Intelligence (national / country specific updates on PV requirements)
Intelligence on local reporting requirements (ICSRs, SUSARs/SAEs, PSURs, DSURs, etc.)