Luto can enhance the clarity and readability of your Package Leaflet using our unique ‘Audience Design Step’ and ensure it meets regulatory requirements

What we offer:

  • Originating Package Leaflet from SmPCs
  • Readability enhancement of Package Leaflet text
  • Compliance with EU QRD template
  • Graphic design
  • Bridging

Our approach

Over the years we have enhanced the readability and written hundreds of Package Leaflets for our clients. There are many things to consider when producing a Package Leaflet (also known as Patient Information Leaflets or PIL), labelling or packaging for medicines.

Luto can review and enhance the readability of your Package Leaflet text. Luto can also originate a  Package Leaflet from the Summary of Product Characteristics (SmPC). We ensure that the Package Leaflet is compliant with the Quality Review of Documents (QRD) template for EU leaflets and can offer advice on how to comply with the QRD template.

Audience Design Step

Our service includes a unique ‘Audience Design Step’ (ADS). This involves input from an experienced team of information design specialists, pharmacists, academics and expert patients to enhance readability of the Package Leaflet.

Graphic design

A well written and carefully designed leaflet can help people find information they need and use the medicine safely. Our graphic designers can follow your existing house style or we can work with you to suggest the best layout for your Package Leaflet. We use clear typography and layout to turn our written words into a user friendly communication. Our iterative approach means that we refine the design based on tests we conduct with real users, learning from how they interact with the Package Leaflet.


As a key market leader in the User Testing field, Luto can offer expert advice on your company’s bridging analysis and strategy. This expertise is based on Luto’s considerable knowledge of patient information.

Where bridging is required, Luto also offer to rewrite the ‘daughter’ leaflet(s) so it is fully aligned with the ‘parent’ leaflet. Luto can also produce a bridging report for submission to the relevant regulatory authority.

Contact us today to discuss your requirements for producing Package Leaflets, labelling or packaging for medicines.