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Blog
Ensuring Labeling Harmonization Amidst a Legal Entity Change
Rama Mohan Rao Chikkam, Senior Director, Global Regulatory Operations and APAC RA, Regulatory Affairs and Drug Development Solutions, IQVIA
Mar 13, 2023
  • Blogs
  • Ensuring Labeling Harmonization Amidst a Legal Entity Change

A strong, efficient labeling team is critical to the success and safety of your drug products. Labeling strategy is especially crucial when mitigating the roadblocks that arise amid a legal entity change. Whether your company is part of a merger, acquisition, or marketing authorization transfer, a legal entity change can bring up compliance risks that if unchecked could lead to patient endangerment, product recalls, and damage to a company’s brand. However, with expert attention to strategy, timeline, and data transfers that account for both companies’ regulations, your new label development will be seamless and straightforward.

The key to successful labeling harmonization is a gap analysis that considers the labeling practices of each company and any deviations between the two. From there, you’ll be able to design a strategy that takes into account these deviations and accounts for any perceived compliance risk. If, however, your labeling team does not have the bandwidth to handle this added workload, you might consider partnering with an experienced vendor that has resources to devote to legal entity change procedures. Begin by reviewing the necessary steps to develop new, compliant labels; from there, you can identify a strategy that works best for your team’s capabilities.

How to Approach Labeling Amid a Legal Entity Change

Once a legal entity change is enacted, labels must be updated to receive health authority (HA) approval at both a global and local level. To ensure compliance and efficiency, follow the step-by-step approach outlined below:

  1. Perform an impact assessment and gap analysis to identify labeling needs, process gaps between the companies, and compliance risks.
  2. Design and implement a labeling strategy that serves as a roadmap for your team.
  3. Transfer the data associated with global and regional labeling documents of all impacted products. Elect the validated data transfer mechanism that works best for both companies.
  4. Submit the new label to local HAs for approval and proceed with implementation.

Where to Learn More

In the recent whitepaper, “Strategies to Achieve Labeling Harmonization Amid a Legal Entity Change,” IQVIA leaders lay out their recommendations for creating an efficient and cost-effective labeling strategy amid a legal entity change and provide greater insight into insourcing versus outsourcing the process. To learn more their recommendations for saving resources and reducing risk, download IQVIA’s comprehensive whitepaper.

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Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.

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Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.

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