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
