Case Study

Global Update for Labeling due to New Core Safety Information

A well-known company based in Germany and Switzerland required immediate assistance with a global update to the labeling due to new manufacturing sites and changes to core safety information. RegPak consultant with experience in global labeling compliance and CCDS took over this project. The project was staggered by market factors such as the number of language requirements for any one region or market. As with most projects of this kind, other issues were identified e.g., outdated package inserts being used, labels having outdated excipients listed, etc.

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