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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

Labeling Function Development

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

Benefits Realized

In addition to many other non-tangible benefits, the regulatory affairs department:

Launched a new global labeling function responsible for all labels
Deployed new tools and technology that improved the efficiency of label development
Adopted one source of contact and accountability for labels

Process Documents Harmonization

Pain Points

Our client was struggling with managing the standard operating procedures and working instructions their staff where supposed to follow. Their function was assigned many SOPs, some of which were not relevant to their activities. In many cases, the SOPs which were applicable to their function had varied levels of detail, in some cases had activities and steps which did not make sense to the function. In addition to internal frustrations with having to read and sign SOPs with unclear activities, the situation presented a compliance risk for the organization as many employees began to either ignore SOPs or read and sign but not use the SOPs.

Our Solution

In collaboration with the process, training and compliance lead for the function, we convened a team of employees from representative departments and developed a framework for them to assess assigned SOPs. The assessment included checking for applicability to their function and accuracy of assigned activities. Specifically, we led the team in:

Reviewing every SOP and identified activities that were applicable to their function
Eliminating SOPs that were not applicable to their function and combining some SOPs
Assigning SOPs to specific departmental roles
Developing an engagement model for the function to interact with the compliance department and the overall SOP development process

Benefits Realized

In addition to many other non-tangible benefits, the function:

Reduced the number of SOPs their employees had to read and sign while reducing compliance risk
Streamlined the process for providing subject matter expertise input to SOP development teams

Tag: Process Optimization

Global Labeling Process

Pain Points

Our Solution

Benefits Realized

Simbai Mudzamba

Labeling Function Development

Pain Points

Strategy Solution

Benefits Realized

Simbai Mudzamba

Process Documents Harmonization

Pain Points

Our Solution

Benefits Realized

Simbai Mudzamba

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