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Top 3 Questions to Ask About Your Regulatory Labeling Process

Conventional translation management tools do not support intricate regulatory labeling submissions approval processes. Currently, pharma organizations must use parallel manual processes to preserve the history of all changes. These changes then need to be painstakingly and very accurately reintroduced into the final delivery documents. This very tedious manual effort results in costly overhead within tight timelines.

Pharmaceutical companies can streamline their complex processes by adopting technology alongside of human resources.

The following key questions help you to define the regulatory labelling process and translation areas that may benefit from technology and automation.

The review process:

  • Is there a way to automate our internal review process?
  • In addition to automating of manual labeling workflow steps, is there an easier way to track where each document is in the translation process?


  • How can we protect against unwanted changes to existing approved text?
  • Is there an easy way to communicate a label change which effects multiple existing label forms and entails disseminating that information to dozens of translators and reviewers?

Multilingual challenges:

  • How can we translate to multiple languages while leveraging existing approved translations?
  • How can we reduce translation time?
  • Can we use a database of existing terminology (controlled words, taglines, product/feature names, slogans/phrases) and their translations to automate updates or new labels?

These questions should be addressed by individuals responsible for this process.  Additionally, manual and administrative translation tasks need to be determined, since this time could be better spent working with regulators.

As a leader in the translation industry and experts in Life Sciences, SDL has assisted organizations in streamlining their operations, lowering the costs, and significantly reducing the complexity of the process.  Click here to find out how SDL can help you.