Beate Beime Pharma Consulting provides support throughout the entire drug approval process, as well as for both drugs and medical devices, including the conduct of clinical trials and readability user tests, thereby ensuring market access for your products.
User Tests / Readability User Tests
We conduct readability tests of package inserts using the interview method. The test method, validated and standardized by Dr. Beate Beime, ensures reliable and, above all, rapid results—which is important for drugs in the final phase of the approval process. We also assist you in conducting user tests.
CONSULTING ON Drug Approval and Clinical Trials
Demonstrating the efficacy and tolerability of your drug or the safety and performance of your medical device requires a smart and regulatory-compliant strategy, professional management of clinical trials (Clinical Trials / Clinical Investigations), and careful documentation at every stage of implementation to support the corresponding submission.
To help you obtain marketing authorization for your drug, 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 drug development as well as the entire regulatory approval process, thereby ensuring market access for your products.