Quality and Compliance are highest priorities for us while handling drug safety and other activities.
PharmaVigil offers specialist expert support and consultancy in matters relating to all types of Good Pharmacovigilance Practice (GVP) Quality Assurance auditing and risk-based audit program development (e.g. Affiliate / Local Operating Company, PV Systems, Marketing Partners, and Service Providers/Vendors).
We also support our clients for Inspection readiness & business partner external audits.
System establishment, PV-QMS & procedural development activities
Safety data collection, evaluation, understanding and prevention of ADRs/AEs
Development & submission of periodic safety writing reports
Global/Local Literature searching followed by classification
Queries (Call/Email) Receipt & Resolution Management
PharmaVigil is equipped with fully supported and regulatory compliant safety database solutions.
Development & submission of PSMF/PSSF, PvMF & PSMF summary as part of module 1.8.2
RMP/REMS Risk identification followed by development of plan