Start-up Pharma company with no REG, PV, Quality systems infrastructure, processes and limited personnel

  • Client start-up with major pharma portfolio asset purchase (approx. 20 products and 450 MAs, across 47 markets).
  • Client has no Regulatory Affairs (RA), Pharmacovigilance (PV) and Quality Management (QM) capacities in-house (neither globally nor locally) to take care of the acquired portfolio and no established systems, tools or processes.
  • Needed support to handle all MAH transfers and subsequent maintenance activities for RA, PV and QM on global and local level.