We offer you professional PIL readability testing / PIL user testing according to latest EU and national requirements. Our readability test methodology is designed by former authority experts who also prepared such tests for several regulatory affairs consulting companies. Participant recruitment and interviews are conducted by company with high experience in readability test interviews which assures proper documentation (audio/video) and compliance with standards which is an important factor in test assessment in MRP and DCP.
Thanks to standardized core of methodology and readability test report, test is less time-consuming and number of issues raised by agencies are lower in comparison with ad hoc tests. Test methodology is in line with Directive 2001/83/EC with amendments, EU Guideline on the readability of the labelling and package leaflet of medicinal product for human use as well as other national requirements i.e. MHRA guidelines which are the basis for Polish PIL readability regulation, BfArM and CBG-MEB guidelines. Besides that we offer you experience in preparation of SmPC, PIL and labelling in line with QRD requirements.
Our offer for PIL readability testing:
► preparation of SmPC, PIL, labelling in line with QRD
► preparation of test questionnaires tailored to tested product
► participant recruitment and test interviews with proper documentation
► implementation of necessary PIL amendments
► preparation of readability test report in English and in Polish so it can be used in MRP and DCP procedures
► bridging studies on the group of products to reduce number of readability test and thus to reduce costs of readability testing.
