Regulatory Affairs Services

Implementation and Reporting Readability Tests

Implementation and Reporting Readability Tests

Our regulatory team shall conduct readability test studies and reports for medicinal products with an ongoing regulatory process or medicinal products licensed after 14.07.2017 but without a sales license as per the “Regulation on the Labelling, Package Leaflet and Tracing of Medicinal Products for Human Use” published in the Turkish Official Gazette dated 25.04.2017.

  • Preparation of a Readability Test Protocol and questionnaire (upon request)
  • Conducting a Readability Test on 20 participants according to Ministry requirements
  • Statistical evaluation of the questionnaire results
  • Preparation of reports
  • Presenting all documentation and voice recordings to the company for sending to the Ministry of Health