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