Regulatory teams benefit from a streamlined, end-to-end publishing process
Miami, Florida – March7, 2019 – ArisGlobal, a leading provider of life sciences software that automates core drug development functions for over 200 life sciences companies, today announced LifeSphere® Publishing, a complete, pre-validated submissions management system that enables life science organizations to easily plan, compile, publish, and validate regulatory submissions with full support for all major global eCTD requirements. LifeSphere Publishing can be used as a standalone application or as an integral part of ArisGlobal’s LifeSphere® Regulatory end-to-end cloud platform for regulatory affairs.
As part of the LifeSphere cognitive platform, LifeSphere Publishing works seamlessly with LifeSphere® EasyDocs, also announced today, to provide a fully unified content and submission management solution. Built on open SOA architecture, the solution offers configurable APIs to enable easy integration with other document management systems such as Documentum, D2, SharePoint, and more.
“Many life sciences companies face an increasing volume of digital assets being created and managed across multiple repositories. This reality makes it extremely difficult to have true visibility into where approved content exists across the organization and potentially leads to compliance issues,” said Wim Cypers, Senior Vice President, Regulatory Affairs of ArisGlobal. “LifeSphere Publishing and LifeSphere EasyDocs, in combination with LifeSphere Regulatory, help users to manage, in a single unified platform, all content related challenges and ensures compliance for years to come.”
LifeSphere Publishing offers feature-rich capabilities that deliver powerful benefits:
- Seamless integration with regulatory information management, document management, and dossier management systems gives companies comprehensive capabilities across the product regulatory lifecycle
- An intuitive, easy-to-use and mobile-enabled user interface enhances the user’s experience for compiling, publishing and validating submissions
- Built-in document management functionalities with lifecycle and workflow management proactively navigate users through assigned activities
- eCTD submission lifecycle management and support for FDA application and submissions ensure compliance
- Pre-validated deployment on the state-of-the-art Amazon Web Services (AWS) cloud eliminates internal infrastructure and need for costly upgrades
Learn more: LifeSphere Publishing