Readability testing and bridging
of package inserts
for European drug approvals
Are you looking for a language service provider for readability testing and bridging, that …
- Answers all of your questions concerning readability testing and the evaluation of package inserts in accordance with European requirements,
- Checks your package inserts or creates the bridging report for you in accordance with the current guidelines (CMDh), and
- Can delegate the translation of your package inserts and other product information into all the required languages?
Then look no further than our comprehensive readability testing service.
From advising to implementation
We can take charge of your readability testing needs.
Package inserts are important sources of information for patients who use your product. Therefore, when designing package inserts, you must comply with numerous legal provisions from the Medicinal Products Act Germany as well as European regulations.
We can help you conduct the legally required readability testing. This will help you to both increase the comprehensibility of your package inserts 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 advise you through all of the processes. We can help answer all of your questions concerning readability testing and assessment as well as bridging of package inserts in compliance with European requirements.
Our tailor-made readability testing service
We make your products ready for use across Europe.
As part of our careful readability testing, we check…
- The package inserts for all of your medicinal products and medical devices,
- The usage instructions for the application systems for 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 and optimization or even production of your package inserts based on ...
- Our regulatory and pharmaceutical expertise
- Our database of almost 200 validated quality criteria
- Our studies on the comprehensibility of more than 2000 medical terms
- Our study experience 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 ready-to-submit PDF version for the CTD module 1.3.4 in any EU language
- Written readability testing that is recognized throughout the EU
- Readability testing in all EU official languages
- A precise evaluation of the testing results
- Standard performance of readability testing in four to six weeks, including systematic optimization/generation of deliverables
- Expedited option to complete readability testing within two weeks
- Tailor-made solutions for checking your package inserts and all other information
- Medical-pharmaceutical expertise and personal point of customer contact
- Bridging studies may be included following the tests if so desired
- Focus testing and bridging may be completed on the basis of the already available results of readability testing of other package inserts
- Readability testing is checked for its suitability to be used as a reference
- Package inserts are harmonized with the reference
- Package inserts are evaluated with regard to content, language level, and layout
We always conduct readability testing and bridging in accordance with current regulations.
A completely well thought-out language service
in the area of readability testing & bridging
- You can rely on us.
Your project manager is your personal 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 our more than 20 years of experience as a language service provider.
- Our reliable time management
We know how important it is to comply with deadlines when having your medicinal products authorized. That is why we always keep an eye on all timelines for the punctual 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 very familiar with all the requirements of the national and European approval authorities. Our committed project managers will take direct charge of coordinating your entire project. That way you can receive the best possible experience.
- 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 adeptly implement your project.