Strategies To Achieve Labeling Harmonization Amid A Legal Entity Change

Building a dynamic and proactive labeling strategy is crucial to the success and compliance of your pharmaceutical products. A strong labeling team is especially vital during legal entity changes, which occur regularly via mergers, acquisitions, or marketing authorization transfers, and bring up numerous challenges for stakeholders, including compliance risks. From a labeling perspective, it is crucial to consider the strategy, timeline, and data transfers necessary to procure and update the labels while accommodating the regulations of the new entity. A failure to properly account for these factors can lead to non‑compliance internally and with regulatory authorities.

To achieve harmonization, the labeling team must conduct a gap analysis of the labeling practices followed by each company. From there, implement a strategy that accounts for any compliance risks and follows an efficient timeline. One solution to prevent strain on your team is partnering with an experienced vendor that can serve as a strategic labeling resource for legal entity change activities. Download the complete article for insight into how best to develop a process, whether insourced or outsourced, that saves resources and ensures compliance for your team.