Cedience

Cedience is a next-generation regulatory intelligence platform enabling regulatory professionals to play an even more central role within their organizations.

Cedience enables regulatory professionals to uncover unique insights on the regulators, answer complex questions on expectations, evaluate trends and decision timelines, leverage past interactions and, of course, monitor changes on granular level.

Here are just of a few examples of the questions Cedience can answer,

- Which EMA products relied on historical control arms?

- Which products received Rare Pediatric Disease Designation (RPDD) for Acute Lymphoblastic Leukemia (ALL)?

- What are the most common reasons FDA denies priority review?

- Which EMA products have been recommended for marketing authorisation following re-examination?

- Are there any examples of complete response letters that are related to the presence of foreign particles?

- Which GLP-1 receptor agonists list thyroid cancer as an adverse reaction and how do the risks compare?

- Were there any issues, concerns or limitations related to the use of fasting triglyceride levels as an endpoint?

- What was FDA's feedback on relying on clinical studies that were only conducted in China?

- Were there any FDA comments or concerns on secondary malignancy risks with CAR T-Cell therapies?

and many more...