CuraGen chooses ESPS's CoreDossierX as regulatory publishing solution



CuraGen, a genomics-based drug discovery and development company focused on merging the life sciences with information technology, will implement the software, currently used by nearly 60 life sciences companies, to streamline their regulatory publishing processes for its biologic license applications (BLAs).

The CoreDossierX software is designed to allow users to access and compile reports and submissions from virtually any input and publish content in electronic and/or paper formats.

ESPS' understanding of regulatory issues in the biopharmaceutical space
has provided a solution that meets CuraGen's needs for assembling and
submitting our investigational new drug applications and biologic license
applications, said Donna Morgan Murray, Director of Regulatory Affairs
and Clinical Development at CuraGen. CoreDossierX appears to offer the
capabilities we need to efficiently publish the large volumes of regulatory
information required for submission to regulatory agencies worldwide and to
meet our objectives for delivering fully paperless submissions to the U.S.
FDA.

CoreDossierX is designed to enable compound document assembly and publishing for large, complex publications. kPublisher offers assembly and publishing capabilities for small-to mid-range reports and documents. The portal uses Web technology to help users manage, review, collaborate, and disseminate the information contained in submissions and other large, complex publications.