The Customer

One of the world's premier biopharmaceutical companies, driven by breakthroughs that change patients’ lives. It applies science and its global resources to bring therapies to people that extend and significantly improve their lives. The client strives to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products, including innovative medicines and vaccines.


  1. Inefficient and non-scalable content, and inconsistency across documents and markets

  2. Inability to create personalized labels 

  3. Limited accessibility for patient

The Solution

Indegene deployed a platform that identified Summary of Product Characteristics (SmPC) changes and classified them as addition, deletion or replacement along with content topics in SmPC and Patient Information Leaflet (PIL) based on  Quality Review of Documents (QRD) guidelines.

We linked PIL sentences to specific source text in SmPC and provided suggestions for PIL content based on changes made in SmPC and with QRD-mandatory content and excipient guideline proposed sections and topics where content should be placed in PIL.

Indegene improves efficiency of creating patient information leaflets
40% ↓
Effort hours for PIL updates
Compliance to QRD and excipient guidelines
Accuracy in generating content from SmPC
Indegene improves efficiency of creating patient information leaflets


  • Indegene furthered this client’s breakthrough mission that change patient’s lives by enabling its patient information labeling operations be future ready

  • We did this by reducing the effort hours for PIL updates by 40%, ensuring 100% compliance to QRD and excipient guidelines, and delivering over 85% accuracy in generating content from SmPC