In terms of electronic submissions to FDA, over the past 2 years, Target Heath prepared and submitted 2 eINDs, 1 PMA eCopy with numerous PMA eCopy supplements and 1 eCTD NDA, with numerous supplements. All submissions were accepted by FDA. We are currently preparing 2 INDs which will be submitted electronically. There are 3 main advantages of eSubmissions: 1) they are paperless and save trees; 2) they dramatically reduce the time from the end of Phase 3 to regulatory submissions; and 3), they earn money as time to market is accelerated.

For more information about Target Health or any of our software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Our software tools are designed to partner with both CROs and Sponsors.


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