Innovative Analytics supports clinical drug/device development programs with standard and innovative data management, statistical, and medical writing services. Our database and analysis processes are ICH and GCP compliant. We have extensive experience with the content of and eCTD formats for US, EU, and Japanese regulatory submissions for various therapeutic areas and orphan drugs. These include INDs and NDAs for drug applications, as well as PMAs and 510(k)s for device applications.

We provide large and small clients with flexible “turn-key” support, resource augmentation, and consulting arrangements.

http://www.ianalytics.biz