Readability testing of patient information leaflets (PIL) is a process designed to test medical product leaflets to ensure the text displayed is “legible, clear and easy to use” for medicine users, as defined by the European Directive 2001/83/EC, and amended by Directive 2004/27/EC.
Since 2005, all manufacturers of medicinal products must pay special attention to the readability test process as it has been a legal requirement in European countries in order to obtain the approval for their product.
At Novalins, our Life Sciences Division has specific involvement in readability user testing and our experts are backed up by the experience of successfully completing hundreds of readability tests in the frame of CP, MRP, DCP and national submissions. We work in close collaboration with Regulatory Affairs specialists to ensure that the patient information leaflet of their drugs and medicinal products are correctly readability-tested.
Our readability test services include:
Novalins offers full readability tests mainly in English but also in other languages, such as Dutch, French, German or Spanish.
In addition to readability testing and bridging strategies, we also assist regulatory affairs specialists with the following main solutions: