Beate Beime Pharma Consulting accompanies the complete approval process of medicinal products, as well as the implementation of clinical studies and readability user tests for medicinal products and medical devices, thus ensuring the market access of your products.
CONSULTING FOR Marketing Authorisation AND Clinical trials
The proof of efficacy and safety of your medicinal product or the safety and performance of your medical device requires an intelligent strategy that complies with regulatory directives, as well as professional management of clinical studies (clinical trials/clinical investigations) and careful documentation for the relevant filing during each phase of implementation.
For the marketing authorization of your medicinal product, we create from gap analysis to the final modules of the eCTD.
Readability User Testing and Usability Testing
We conduct a readability test of the package information leaflet by an interview procedure. The test methods validated and standardized by Dr. Beate Beime ensure reliable and, above all, fast results – important for drugs in the final phase of the approval process. We also support you with the realisation of Usability Testing.
About us
We bring more than 25 years of experience in drug development and the registration process for medical products, thus ensuring that your products gain access to the market.