Readability User Testing
According to Directive 2001/83/EC as amended by Directive 2004/27/EC, the readability of the labelling and package leaflet of medicinal products for human use became mandatory across the European Union, requiring that consultation with target patient groups (‘user consultation’) be carried out to demonstrate the readability and usefulness of the labelling and package leaflet to patients.
Assion offers testing on all forms of patient information for all product types, including devices, and dosage form and have established quality standards throughout the process. Successful Readability User Testing reports have been generated for all product presentations in respect of National, CP, MRP and DCP submissions throughout the EU.
Examples of Services are:
- Writing protocol and questionnaire development
- Critical Assessment and review of existing leaflets
- Writing and designing a leaflets
- Creating a leaflet template for a product portfolios
- Arranging and undertaking one to one interviews
- Writing the final “submission ready” reports
Old molecule for a new indication an Assion case study
A US start-up business, specialising in the field of gastroenterology, was looking to repurpose an old molecule for a new indication encompassing a different route of administration.