ADVANCED R&D LIFE SCIENCE SOLUTIONS
Enterprise Content Management (ECM) is now considered mission-critical functionality for life sciences companies to effectively organize, manage, and assemble regulatory submissions. Today’s highly regulated R&D environment demands that organizations simplify their regulatory content and submission-management effort to achieve sustained competitive advantage. Progressive organizations are beginning to combine project management, document management, and regulatory submissions management as a comprehensive solution to address a broad set of Regulatory Affairs requirements.
To meet current challenges, today’s best practices require solutions that allow regulatory affaires professionals to address their day-to-day tasks, from document to dossier creation, compilation and maintenance, deficiency and variation handling, paper and electronic submissions, as well as comprehensive planning and reporting with enterprise-ready technology suitable for a compliance systems environment.
R&DExpert™ is a comprehensive, pre-configured solution that addresses the unique content management requirements of Regulatory Affairs. The solution delivers seamless integration with regulatory content management, scan/input capture, extensive ad hoc and custom reporting, electronic regulatory publishing, and much more. Uniquely, R&DExpert™ includes templates to support Virtual Documents® ready for publishing in eCTD, or any other required format.
R&DExpert™ is available in multiple languages to support a multi-cultural work environment.