Medical product labeling is a highly regulated and complex process. Oftentimes pharmaceutical companies turn to specialized outsourcing organizations to augment their expertise and staff. A top 5 global pharmaceutical company required support for their global product labeling operations, specifically on the creation and/or revision of their product labeling in accordance with their standard operating procedures (SOPs) and as required by the relevant Health Authorities (HAs). The pharma company moved to an outsourcing model for managing the following activities:
- Creating and/or revising the content of internal (i.e., Core Data Sheet) and United States product labeling (USPIs and patient labeling)
- Distribution of labeling revisions to internal stakeholders for approval prior to HA submission
- Storage and maintenance of labeling documents in accordance with the client’s standard operating procedures
- Maintenance of labels’ regulatory status in the client’s document storage system
- Management of orders to convert revised USPIs to the Structured Product Labeling (SPL) format
By employing a labeling operations and management model that takes advantage of a specialized vendor in regulatory and labeling activities, organizations can reap the following beneﬁts.
- In-house resources are able to devote their time to more productive and strategic activities
- Costs are reduced by implementing an optimized global resource model by strategically locating most of the team off-shore
- Capacity to meet volume fluctuations and tight due dates, for example, fast reactions to HA questions and amid HA transactions
- Efficiency and compliance gains with internal and regulatory-driven timelines
- QC and QA process rigor that strengthens their reputation with HAs by setting a high standard of quality for labeling submissions
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