Pharmacovigilance

Lambda, as a Pharmacovigilance (PV) Partner, provides end-to-end pharmacovigilance and Materiovigilance (Pharmacovigilance for medical devices) services along with a flexible range of safety monitoring services to precisely compliment client’s needs.

 

Lambda is currently performing end-to-end pharmacovigilance for over 4000 authorisations globally, involving all therapeutic areas including oncology, anti retrovirals, biological and more. We also provide end to end vigilance services for Global clinical trials.
  • Promotes optimum patient safety, product stewardship and meets most comprehensive regulatory requirements
  • Robust and compliant Systems & Processes
  • Pharmacovigilance Safety Database – an E2B compliant advanced software solution that offers complex data analysis and querying of safety data sets, thus proactively meeting all risk management requirements
  • Regulatory Inspections – Over fifteen Pharmacovigilance regulatory inspections (including MHRA – United Kingdom, US FDA, AIFA – Italy, Polish MOH, FAAG-AFMPS – Belgium, CBG-MEB – Netherlands) have been conducted at Lambda over the last couple of years.