Product Information

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Product Information

Our experience and the number of successfully delivered projects endorse our Product Information services:

Summary of Product Characterisitics, Package Information Leaflets and Labelling

  • Compilation and preparation of SmPC from available clinical studies and available literature according current EU requirements and guidelines.
  • Preparation of PIL and labelling according current EU requirements and guidelines.
  • Updates and revision according to the current legislation.
  • Support during national phase adjustments.
  • Braille certificates.

Mock ups and artworks

  • Mock up creation for leaflets in the most suitable format, according to standard symbols, fully compliant with the current legislation.
  • Mock ups for labelling in multiple formats according to the type of primary and secondary packaging.
  • Art work designs for product launch.
  • Implementation of changes following variations.

Consultation with target patient groups (Module 1.3.4)

  • Readability User testing in different populations and languages.
  • Altiex Life is leader providing readability testing services. We are able to conduct the readability test in national languages if required. Our experience and the number of successfully delivered projects endorse our Readability User Testing service.
  • The test is conducted on 24 participants through three rounds of face-to face interviews.
  • The following services are included:
    • PIL revision and update to current QRD Template and local requirements.
    • Mock-up creation
    • Design of protocol and questionnaire
    • Three rounds of testing and preparation of the final report
  • Other forms of patient consultations:
    • Bridging reports
    • Focus tests
    • Reference to already approved package leaflets
  • Assessment to suggest the best choice of consultation form (technical, time and cost effective).
Because we are aware of the role of the Patient Information Leaflet in an information-rich society.
Registered Office
  • Nám. 14. října 2/1307
  • 150 00  Praha 5 
    Czech Republic
  • Tel: +420 222 351 874
  • Fax: +420 222 351 875