Our readability user testing is characterized as follows:
- Individual interviews with 20 trial subjects from the target group of the drug.
- Readability user testing in English, German, Romanian or Croatian with native speakers.
- Direct assessments after each interview enabling quick corrections of incomprehensible passages.
- When text comparison permits: bridging study or focus test will be carried out for you.
- Preparation of all documents for the CTD module 1.3.4 for ﬁling.
Benefits for you:
- High standard and thus approval by all European authorities including EMA in DCP/CP!
- You will receive the final report in English within four weeks of sending the final mock-ups!
- Validated and reliable readability testing!
- Audited by the pharmaceutical industry!
- We have many years of experiences with this procedure in Europe!
Furthermore, we offer support during drafting, revision and formulation of the labelling documents, and of course we will also provide you with regulatory support in this respect!