Labeling Archives | Proficio Consulting Group

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

Pain Points

Our client's R&D organization, specifically the regulatory affairs department, did not have clearly defined roles and responsibilities for developing content for labels, managing the label development process and maintaining approved labels. This created a compliance risk, inefficiency in the end-to-end labeling process and a lack of organizational control of labels for our client.

Strategy Solution

In collaboration with regulatory leads, we were tasked with developing a strategy for the management of the end-to-end labeling process. A major component of the strategy was a business case for a function to manage and control the labeling process. The solution we developed included:

Newly defined functional and individual labeling roles and responsibilities

High-level benchmarking of organization of labeling departments at other organizations

Internal resource assessment and analysis for optimal resourcing of the labeling function

A solid business case for a new labeling function within the regulatory affairs department

Tag: Labeling

Global Labeling Process

Pain Points

Our Solution

Benefits Realized

Simbai Mudzamba

Labeling Function Development

Pain Points

Strategy Solution

Benefits Realized

Simbai Mudzamba

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