Due Diligence Services
Safety Due Diligence for a Newly Acquired Medicinal Product Portfolio
iVigee will check for regulatory actions, safety issues, intellectual property or any disputes that may affect the medicinal products portfolio in question.
Due Diligence of Pharmacovigilance Providers Prior to Acquisition
iVigee may provide a full review of a pharmacovigilance provider including benchmarking data, knowledge levels and expertise, and perceived outlook and competitive positioning versus comparable service providers. Summarized for data driven decision making.
Due Diligence of the Pharmacovigilance System Prior to Corporate Changes
iVigee can provide a full due diligence review of an internal or external PV system before a major corporate event occurs. Merger, integration of multiple PV systems or portfolio acquisition.
Impact Analysis of Portfolio and Geographical Changes
EU GVP requires the EU QPPV to run an impact analysis of any such changes to the portfolio or geographical coverage of a portfolio with regards to the PV system. This procedure can be outsourced to iVigee and documented for regulatory authorities review.
