PharmaVigil is equipped with fully supported and regulatory compliant safety database solutions for you to remain adhere to the applicable regulatory recommendations.
The system is compliant with FDA 21 CFR PART 11 and EU GMP Annex 11 and are validated following GAMP 5 guidance.
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