Labeling challenges for Generic manufacturers
Generic pharmaceutical companies have a significant number of products spanning multiple therapeutic areas and geographies. Regulations, in the near future, would require generics to proactively update their product labels when there is sufficient data to support a change as opposed to following an innovator update. Moreover, the sheer number of products that need to be supported exerts maximum stress on a generic manufacturer’s ability to make time-sensitive critical safety updates of their products. The process is even further complicated as the updates have to be tracked and effected in other regions as well. Compliance to new and evolving regulations requires generic pharmaceuticals to address product labeling in a more proactive manner.
How does Managed Services solve these challenges?
Sciformix’s Managed Services provides a centralized and integrated ecosystem for creating new labels and labeling updates. It helps you update labels in a time critical manner by enabling you to store, classify, prioritize, retrieve and update all labeling data through the organization in a systematic way. Our platform fosters organization-wide proactive collaboration, communication and management of the labeling process. In an environment where a pool of products have to be updated or in the case of a sudden surge in the number of label updates, it is essential to prioritize the work based on the safety concerns. We help you set up priority activities and communicate the priority list to all stakeholders (internally and externally to the organization). Users can accumulate, share or distribute the source document (existing label) to stakeholders, allowing them to create, import and track information through a single interface. The platform can plug into existing legacy systems allowing users to access and edit information, and track their actions in multiple legacy systems through a single interface.
Structured, customizable process and work flow management
A safety update that has to be reflected in the global label and regional labels within a stipulated period of time can be actively managed and delivered through Sciformix’s Managed Service platform. It allows you to set timelines for critical activities and prioritize them against parallel projects. The countdown for the delivery day is shared with all the stakeholders to ensure focus, prioritization, synchronization and tracking.
Source data is accumulated through the customizable information capture template that acts as the common source of data for all stakeholders through the entire label cycle, thus minimizing downtime accessing and sharing data from multiple sources. It also enables tracking of documents and managing the edits or changes in label with a complete audit trail.
Standard templates, like QRD and PLR for EU and US are built into the engine, allowing you to choose the default style and format to keep you compliant. The templates also allow you to auto populate information in the template, ensuring significant time saving and quality enhancements.
The QC module allows you to compare the template and highlight the difference in content, style and format. The engine’s two-way and three-way comparison tables and the auto generation of change logs play a vital role in documenting and ensuring compliance towards audit readiness. This reduces manual intervention by allowing quick review of labels by the labeling experts and quality personnel.
Unique request IDs are created to tag and manage other child requests and can be linked to dependent labels/countries. The engine detects and maps CDS changes to all applicable LPDs, as part of the same project file and allows you to manage non-English language LPDs as well through a reporting and analytics dashboard.