Single solution for global tracking
- Integration with RIMS, DMS, and dossier management
- Ability to manage and assign publishing jobs
- Support for parallel submissions
- Incremental publishing and export capabilities
- Built-in document management capabilities with sophisticated documents lifecycle and workflow management
- Sophisticated PDF management including hyperlinks and bookmarks
LifeSphere Regulatory Publishing
LifeSphere Regulatory Publishing has been built as an integral part of the LifeSphere® platform, based on ArisGlobal’s Industry Standard Practices (ISP) and pre-validated, secure, multi-tenant cloud-based architecture. The unified platform provides the entire regulatory organization – regulatory affairs headquarters, regulatory operations, regional regulatory managers and local affiliates with capabilities for planning, tracking, data management and reporting needs covering the complete product regulatory lifecycle on a global basis, and includes functionality to support data standards compliance (IDMP, xEVMPD, etc.).
LifeSphere Regulatory Publishing ensures that published dossiers are compliant with ICH and regional specifications and allows life sciences companies to maintain a comprehensive overview of dossier electronic submission statuses. With add-on LifeSphere® DMS capability, our solution can support comprehensive document content, version and lifecycle management, including support for workflows with alerts to guide the process of authoring, reviewing and finalizing documents.
Built on open architecture, the LifeSphere platform also integrates with other document management systems such as Documentum, D2, SharePoint, Veeva Vault DMS, and more, using configurable APIs for seamless connections.
ArisGlobal’s LifeSphere Regulatory Publishing solution can be used as a standalone application or along with other LifeSphere® Regulatory modules for a true end-to-end platform. This comprehensive, feature rich solution leverages a web-based user interface for compiling, publishing and validating submissions as per eCTD standards.
This tool currently supports US FDA eCTD 2.02 and 3.2 and will soon accommodate eCTD 4.0 and all major regional eCTD requirements (by September 2019).