LangCor Service GmbH offers to perform a representative study of the readability of your package leaflets for representative products from the respective target groups in accordance with the regulatory requirements of the EUROPEAN COMMISSION ( GUIDELINE ON THE READABILITY OF THE LABELLING AND PACKAGE LEAFLET OF MEDICINAL PRODUCTS FOR HUMAN USE 12.1.2009) in one of the EU Member States.
Our services include, for example:
Planning the conduct of your readability study according to your regulatory deadlines
Advice concerning the optimisation of your package leaflets and their layout according to the regulations of the lead EU Member State for your procedure.
Coordination of the conduct of the study with our external subject experts or a testing centre of your choice
You will receive reliable study reports, which are specifically designed for use in extensive bridging studies. Our experts will also readily advise you on the development of a European readability compliance strategy, in order to keep the costs of readability user tests as low as possible.
Registrated to DIN EN ISO 17100:2016-05