ProductLife Group Steers Small Pharma Client to Positive Opinion From EMA PLG Guides Client through RMP Complexities, Leading to Expanded Partnership www.productlife-group.com PAGE 1 OF 2 Outsourcing and Consulting Services for Life Sciences CASE STUDY THE CLIENT A small, emerging Australian pharmaceutical company with one orphan drug product set to receive marketing authorisation in Europe PROJECT SCOPE At the outset, ProductLife Group (PLG) was asked to take on the role as qualified person for pharmacovigilance (QPPV), with a client plan to expand the role to one of providing postmarketing services. Soon after the project began, however, PLG was also asked to step in to both update the risk management plan (RMP) and manage the pharmacovigilance system master file (PSMF). Th

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