The directives released by global regulatory authorities require each application for marketing authorisation to have a Pharmacovigilance System in place including the PSMF & qualified persons. PharmaVigil is uniquely placed to support you establishing/upgrading your Pharmacovigilance System in accordance with the applicable regulatory recommendations.
We have expertise in designing and developing PV systems for start-ups to well established pharma companies.
Render support in integrating PV system with the existing Quality Management System (QMS), alternatively the team develop and implement QMS.
Preparation of PSMF & SDEAs customized per applicable global regulatory requirements including company procedures.
Customized approached in-line with the local applicable regulations i.e. development of PSSF & PvMF document for Arab countries and India respectively, support in registration of QPPV in EudraVigilance, LSR in Arab league countries and PvOI in India .
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.
Quality and Compliance are highest priorities for us while handling drug safety and other activities.
Development & submission of PSMF/PSSF, PvMF & PSMF summary as part of module 1.8.2
RMP/REMS Risk identification followed by development of plan