Our readability user tests for:

 

  • Package leaflets (PL) / Information for the patient for medicinal products

  •  Instructions for use (IFU) for medical devices and technical equipment

 

is characterized as follows:

  • Individual interviews with 20 trial subjects from the target group of the drug / medical device.

  • Readability user testing in English and German 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 filing.the drug CTD module 1.3.4 or for the technical documentation of your medical device.

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Benefits for you:

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  • 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 testing procedure!

  • Experience in the interview process since the legislation entry in 2005!

Furthermore, we offer support during drafting, revision and formulation of the labelling documents. Of course, we will also provide you with regulatory support in this respect!