Pack Insert Readability testing according to EU guidelines

All Patient Information Leaflets (PILs) for new products have to undergo readability user testing

Archemin’s multilingual team – Dutch, French and English – offers full PIL user testing services in compliance with both EU and national guidelines!

A full report, including description of the test procedures and documentation of the outcome, is provided. This com­prehensive document in support of the proposed Patient Information Leaflet is provided, ready for inclusion in the CTD, without additional work.

Preliminary advice

  • Patient-friendly wording
  • Layout / development of a "house style"

Developement of a standardised protocol and questionnaire

  • Specifically designed for the product to be tested
  • Ensures adequate coverage of all relevant issues

Volunteer test panel

  • Experienced interviewers
  • Testing in French, Dutch or English

Analysis

  • Clear proposals for readability improvement

Final report

  • Comprehensive documentation
  • Ready for inclusion in the e-CTD
  • Proven quality

Want to know more / require a quote?

Send your request to mi [at] archemin.eu