Readability testing and bridging
of package leaflets
for European authorizations of medicinal products
Are you looking for a language service provider for readability testing and bridging that …
- supports you in all matters concerning the readability testing and evaluation of package leaflets in accordance with European requirements,
- checks your package leaflets and creates the bridging report for you in accordance with the current guidelines, and
- can translate your package leaflets and other medicinal product information into all required languages?
Then look no further than our comprehensive readability testing service.
From advice to implementation
We can take manage your readability testing needs.
Package leaflets are important sources of information for patients using your product. Therefore, when designing package leaflets, you must comply with numerous legal provisions from the German Medicinal Products Act and European regulations.
We can help you conduct the legally required readability testing. This will help you to both improve the understanding of your package leaflets and foster trust in your product.
Together with our long-term partner in the field of readability testing and bridging, we will be at your side to guide you through all processes. We can help answer all your questions concerning readability testing and assessment as well as bridging of package leaflets in compliance with European requirements.
Our service for customized readability testing
for regulatory affairs
As part of our careful readability testing, we check…
- the package leaflets of all your medicinal products and medical devices,
- the usage instructions for the application systems of your medicinal products and medical devices,
- patient information sheets and informed consent forms for all types of studies, and
- any other medicinal product information.
- Precise checking & optimization and production of your package leaflets based on ...
- Our regulatory and pharmaceutical expertise
- Our database of almost 200 validated quality criteria
- Our studies on the understanding of more than 2,000 medical terms
- Our study outcomes with over 10,000 participants
- The development of an individual questionnaire for each product
- Two test rounds with at least 20 participants
- Final report as a PDF version ready for submission for the CTD module 1.3.4 in English and for translation into other languages on request
- Written readability testing recognized throughout the EU
- Readability testing available in all official EU languages
- Precise evaluation of the testing results
- Performance of readability testing in four to six weeks
- Expedited option to complete readability testing within two weeks (focus test and bridging)
- Customized solutions for checking your package leaflets and all other information
- Medical-pharmaceutical expertise and personal point of customer contact
- Bridging studies can be included following the tests if required
- Focus testing and bridging may be completed based on existing outcomes of readability testing of other package leaflets
- Readability testing is checked for its suitability as a reference
- Package leaflets are harmonized with the reference
- Package leaflets are evaluated with regard to content, language level and layout
We always perform readability testing and bridging in accordance with current guidelines.
A flawlessly designed language service from beginning to end
in the field of readability testing & bridging
- You can rely on us.
Your project manager is your personal point of contact. They will provide you with expert advice and guide you through the entire process. - mt-g's complete service package
We combine our regulatory and pharmaceutical expertise with almost 25 years of experience as a language service provider. - Our reliable time management
We know how important it is to comply with deadlines during the authorization process of your medicinal products. That is why we always monitor all timelines for the timely submission of your documents. - Outstanding process competence
Our long-term partner has an extensive scientific study base and technical expertise in the field of readability testing and bridging. In addition, our partner is deeply familiar with all the requirements of the national and European regulatory authorities. Our committed project managers will take direct charge of coordinating your entire project. This ensures that you will always receive the best possible outcome. - Two reliable partners committed to your success
We have been performing readability testing and bridging together with our partner company for many years. Together we will complete your project to the highest standards.
