Client Case Study: Ensuring SDEA Oversight and Harmonization in an M&A Context

The pharmacovigilance (PV) function of a top 20 pharmaceutical company faced challenges in the management and maintenance of their Safety Data Exchange Agreements (SDEAs) following multiple mergers and acquisitions (M&A).

Navitas helps clients in reestablishing oversight of SDEAs following Mergers and Acquisitions (M&A)

  • Establish a strategic management framework
  • Design and implement tailored governance model
  • Define standards,mechanisms, and metrics for management oversight
  • Clarify roles and responsibilities

Read more about how Navitas helped develop a management framework, update SDEAs and procedures, and manage the consolidation of documents into a single repository that gives the client confidence in their compliance efforts.


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