Gap Analysis and Data Migration

Key Role of PV Data Gap Analysis during Business Mergers and Product acquisitions

The Pharmaceutical industry may acquire the licenses of other authorised products from different marketing authorisation holders (MAH), or they may acquire the full organisation as a one of tactic strategy for business expansion worldwide. As an outcome of such an event, regulatory authority expects a "Due Diligence of Pharmacovigilance Data" between previous MAH and current MAH, which should be authorised by the QPPV of each organisation.

For the assurance of due diligence activity, it requires to perform the Gap Analysis of legacy data, by verifying the availability of all required data, accuracy of the data provided for achieved regulatory compliance for routine or additional pharmacovigilance activities or risk minimisation activities as applicable and provided by the previous MAH.

Key Role of PV Data migration after Business Mergers and Product acquisitions

Followed by this Gap Analysis activity, it may require performing the Data Migration activity, by preparing required documents like "Data Migration Plan", "Risk Assessment" and "Data Migration Summary Report". This can be a manual data migration or fully / partly electronic data migration based on the receipt of E2B and non-E2B data from previous MAH.

Our Solution for Complete Gap Analysis and Data Migration Activity

AllyWorth, supported by the team of experienced professionals, has managed the Gap Analysis activity for many giant organisations with complex pharmacovigilance processes. A team of AllyWorth has also managed the "MAMMOTH" Data Migration activity for more than 100,000 cases to be migrated after excluding the duplicate cases, which are already available within the Global Safety Database.

The documentation of this due diligence activity, followed by Gap Analysis and Data Migration activity is one of the crucial activities to be inspected by any authority personnel during regulatory inspection as a part of "Merger and Acquisition Event". Considering the high complexity of this entire activity, it is crucial to collaborate with a seasoned and trustworthy service provider like AllyWorth to secure the optimal regulatory compliance.