The accelerated introduction of new regulations and guidelines for pharmaceutical labeling industry during past few decades, demands companies to be pro-active in terms of the implementation lifecycles. The dire consequences associated with the erroneous label on a drug or a medical device accounts to severe health risks for the patients. Physicians rely on the label instructions and integrity of the information on the label while prescribing to patients, which further makes it unavoidable for companies to roll out their products with inaccurate labels. However, with the changing landscape of labeling guidelines, released by major health authorities around the globe, the execution challenges emerge as major obstacles in the lifecycle. It further becomes a rigorous task when companies carry out their expansion plans and new geographies are involved. Let’s discuss some major challenges that companies generally stumble upon when it comes to global labeling management.
Collaboration between Global and Regional Teams
Business expansions are obvious in the pharmaceutical industry which in turn demands cross-functional coordination among the teams established across borders. Every geography demands distinct regulations to be followed by the manufacturers in order to make it easy for the regional end users to understand the label instructions easily. In order to manage the language complexities, pertinent harmonization amid regional and global teams becomes fundamental.
Global labeling management is set on the foundation of huge volumes of drug and medical devices data scattered over a wide range of sources. Many times this information is distributed in unstructured files and formats which make it difficult for companies to pull out all the relevant information and consolidate it. Information stored at multiple sources further accounts to duplicate records mainly because of different regional versions available across different geographies. In other words, the “single source of truth” is missing here. Since the compilation process is an arduous activity mostly undertaken manually; the possibility of landing on error-prone end-results are quite high.
Incompetent Tracking Process
This activity commonly involves a robust technology in order to monitor the labeling lifecycle progress by tracking and maintaining the repository of products. Failing to deploy a robust global labeling management software solution, companies can witness ineffective tracking that could result in high risk of mislabeling and counterfeit drugs leading to product recalls, affecting overall finances of the organization.
Knock Over these Challenges with Freyr
Freyr is a strategic global partner for labeling change management and helps its clients navigate through the complex labeling processes with an end-to-end labeling Center of Excellence. Freyr’s Labeling solution has won a finalist spot along others like Merck in CPhi Pharma Awards 2016 for Excellence in Pharma: Regulatory Procedures and Compliance, which streamlines end-to-end Regulatory labeling practice in a company of any size. Right from creation, tracking and managing Company Core Data Sheet (CCDS) deviations, CCDS updates, and developments to creating, implementing, and inspecting multi-lingual regional labels as well as custom reporting.
Get in touch with our experts to overcome the ever-evolving regulatory labeling environmentto manage the complexity of process (Core and Regional) with a centralized label lifecycle management platform.