Pharma & Biotech

Global Labeling

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Concerns

Life Sciences companies consume a huge amount of resource and time managing labeling content contained in Core Data Sheets (CDSs), Package Inserts (PIs), and Summaries of Product Characteristics (SmPCs). Content is often replicated in numerous labeling documents for varying drug indications, dosages and strengths. This results in a huge volume of highly complex labeling content that is difficult to create and manage. There is significant risk of errors and omissions that can only be overcome with complex processes and people. The issues are compounded by strict and evolving rules for the submission of labeling content to global regulatory entities.


Solutions

Author-it Global Labeling brings component-based reuse to the creation and management of labeling content improving efficiency while reducing errors and omissions, with resulting benefits to regulatory compliance, time to market and patient safety. Author-it is the modern component-based successor to outdated document based or complex XML systems. It facilitates reuse, and single source production of labeling to any output be it online or in print. Component-based content can easily be reused across labeling documents, and localization costs can be reduced by an industry leading 80% or more.

_LABELING

Download the Author-it Global Labeling™ Datasheet to learn more about the features and benefits for the Labeling Solution.


Benefits

  • Reduce regulatory risk Simplify overall review cycles with a clear audit trail, reducing regulatory risk and ensuring content consistency across multiple channels.
  • Faster time-to-market Efficiently manage and develop content workflows for content authoring, review, management and translation.
  • Facilitate reuse of Core Data Sheet content Improve efficiency content creation streamlining localization processes with faster review cycles.
  • Improve patient safety Be certain the information provided is accurate and up-to-date to ensure patients understanding.

Learn More

If you're ready to learn more, view one of our white papers or video, or request a consultation to discuss if this solution is right for you.

Whitepaper

Why Components: A Modern Approach to the World's Content Problem

Webinar

Don't let localization negatively impact your global labeling content

Case Study

This Global Company reduced costs by +$2M and exceeded time to revenue