Beate Beime Pharma Consulting provides comprehensive support for the entire marketing authorisation process, as well as for medicinal product and medical devices, including the conduct of clinical trials and readability user tests, thereby ensuring market access for your products.
Readability tests and
user tests / Readability user tests
We conduct readability tests on package inserts using the interview method. This test method, validated and standardized by Dr. Beate Beime, ensures reliable and, above all, rapid results—which are crucial for medicinal product during the final phase of the approval process. We also assist you in conducting user tests.
marketing authorisation , and Clinical Trials: Guidance
Demonstrating the efficacy and tolerability of your medicinal product —or the safety and performance of your medical device—requires a smart, regulatory-compliant strategy, professional management of clinical trials (Clinical Trials / Clinical Investigations), and meticulous documentation at every stage of implementation to support the corresponding submission.
To obtain market approval for your medicinal product , we handle everything from the gap analysis to the final eCTD modules.
About Beate Beime Pharma Consulting
With over 25 years of experience, we advise on, plan, and organize medicinal product developments as well as the entire approval process, thereby ensuring market access for your products.