Readability Testing

Sofus has many years of experience user testing Rx and OTC products as well as herbal remedies. Since 2006, we have performed more than 40 successful readability tests as well as several bridging and layout tests.

We manage the entire test process – from the creation of the leaflet to the final report and our knowledge and experience in regulatory affairs and authority contacts ensure a successful outcome. We develop study protocols and questionnaires, recruit study subjects, perform tests and interviews and write full summaries of test results.

According to the directives for pharmaceuticals that came into effect as of October 1st 2005, readability tests shall be performed as a part of the application for approval for pharmaceutical products.

The readability of the package leaflets shall be tested in connection to the approval or where significant changes are made to the package leaflet.

To read the complete brochure, please click here.