Global Labeling Process

Pain Points

The Regulatory Affairs department at a specialty pharmaceutical company was having difficulties developing content for their labels, getting consensus on labeling changes, keeping track of updates and ensuring label changes were implemented. In addition to internal frustrations with an undefined and unclear labeling process, the situation presented a compliance risk for the organization. We were tasked to develop a cross-functional labeling process to mitigate these risks.

Our Solution

In collaboration with regulatory leads, we developed an end to end cross-functional labeling process to ensure an efficient and compliant process. Elements of the end-to-end labeling process included:

  • Clearly defined triggers for labeling development or updates
  • Clearly defined roles and responsibilities for labeling team members
  • Roles and responsibilities for governance teams and committees
  • Tools to be used in the development of the labels, quality checking and proofing, decision tracking and implementation monitoring

Benefits Realized

In addition to many other non-tangible benefits, the Regulatory Affairs department:

  • Was able to develop a business case for a stand-alone labeling department to manage the global labeling process
  • Updated all labels using the newly defined process
  • Had a streamlined process for label development that everyone followed
  • Reduced the risk of inaccurate or inappropriate statements in their labels

Simbai Mudzamba

Practice Leader

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