Revision of SmPC, PIL and labelling / PIL Readability Testing

RPN offers vast services in connection with product and patient information. We can support your company in the preparation, translation and revision of summaries of product characteristics, labelling and PILs, as well as adaptation to QRD format.

RPN has wide experience in the readability testing:

• Full readability test execution (protocol development, recruitment and interviewing, preparation of the final report to be included in module 1.3.4)
• Preparation of justification for exemption from readability testing
• Support in the establishment of applicable ‘bridging strategies’
• Preparation of bridging reports