Calyx RIM Publisher

Calyx RIM® Publisher enables you to create a complete submission package.

• Use submissions wizards to streamline the initiation of submissions that comply with ICH, Japanese, EU, US, STF, GCC, Swiss, AU, TH, Canadian, JO, CN, EAEU and TW specifications.
• Quickly create all the necessary components for a paper submission, compliant NeeS, or compliant eCTD submission, including the required ICH, STF, and regional XML files, the correctly named leaf files and folder structures, and any requisite navigation aids.
• Easily manage subsequent amendments, supplements and variations to your submissions using intuitive right-click menu options and simple drag-and-drop features, making all updates in the context of the full application.
• Create multiple submissions in multiple regions using comprehensive, built-in templates.
• Automatically transform documents in multiple file formats into enhanced PDFs with bookmarks and hyperlinks.
• Move seamlessly from product registration management to submissions management to publishing your submission to tracking your data.
• Enhance your organization's efficiency, reduce your time to market, and be assured of compliance with the latest regulatory guidelines and specification.