Liquent Regulatory Solutions for Life Sciences

Home > Regulatory Software > Assembly & Publishing > Submission Publishing: Submission Accelerator for eCTD

Submission Accelerator™ -- a complimentary module for CoreDossier® -- automates the assembly and publishing of compliant eCTD dossiers, including the XML backbones for regional content.

Simply drag and drop your documents into CoreDossier with Submission Accelerator and publish compliant output for review by regulatory authorities worldwide.

This CoreDossier companion further strengthens your publishing investment with the following benefits:

• Automated: Automatically generate eCTD-ready documents compliant with ICH and regional specifications and then easily manage subsequent updates across regions and multiple submissions as those specifications change.
• Efficient: Seamlessly repurpose information across submissions using the familiar CoreDossier interface and realize the strategic business advantages inherent in the eCTD format -- finally making simultaneous submissions to multiple regions a reality.
• Compliant: Easily create all the necessary components for an eCTD submission -- documents, XML backbone, file/folder structures – in compliance with the final ICH Step IV eCTD specification and draft specifications from the FDA and EMEA.
• Proactive: Confidently begin evolving your internal processes now to meet upcoming eCTD requirements thanks to a reliable rules-based approach that facilitates easy updates due to changes in regional guidances. Liquent can quickly provide you with template updates to accommodate new regional requirements -- and you don’t have to reconfigure or completely re-validate your publishing environment.

Along with Submission Accelerator’s leading assembly and publishing technology, a complementary state-of-the-art XML viewer is shipped with every Submission Accelerator. With Liquent eCTD Reviewer , you can perform quality reviews and edits of your eCTD submissions. If you are also using a document management system such as Documentum®, Submission Accelerator helps you use your document metadata as a part of your eCTD leaf attributes.

There is no faster or easier way to compete on a global scale than with the automated eCTD publishing capabilities of CoreDossier with Submission Accelerator for eCTD.