LifeSphere® Submissions consolidates submissions and publishing workflows in a single solution that makes it simple to create, compile, and publish submissions in any format.
Discover the Benefits of LifeSphere Submissions for your organization.
- Streamlined Submission Management – Leverage built-in workflows that make it simple to create, compile, and publish submissions starting from a global submission package and automated compilation of national submissions
- Worldwide Compliant Publishing – Publish national submissions in any required format, including electronic and paper publishing in compliance with HA requirements.
- Unified Solution – Drive efficiencies by bringing your submissions and publishing features as part of the end-to-end RIM workflow.
- Reduce Rework – Build submission templates and regulatory knowledge to reuse across different teams and regions.
Seeing is believing
Deliver real value with LifeSphere Submissions.
Deliver real value with LifeSphere Submissions.
Publishing Support
Support for a variety of formats, including eCTD, NeeS, PDF, and XML.
Dossier Record
Maintain the current registered dossier position and its version history.
Regulatory Knowledgebase
Safekeep knowledge on national, regional submission requirements.
Submission Reuse
Compile global submissions to use as the basis for national submissions.
Document Propagation
Readily move documents from global to local submission dossiers.
Submission Automation
Assisted compilation of submissions into predefined submission outlines.
Resources for Your Regulatory Journey
Reimagine Regulatory with Gen AI Technology
LifeSphere Regulatory is not your regular Regulatory offering. Reimagine the value Regulatory can deliver using the latest technologies, including Gen AI and LLM features, across the end-to-end Regulatory lifecycle.
Regulatory Platform Innovation Checklist
It’s time to reconsider how your Regulatory platform serves you. Our checklist outlines what to keep in mind to optimize your bottom-line, harmonize your ecosystem, and drive competitive advantage.
LifeSphere Regulatory Fact Sheet
We’ve created the most comprehensive and innovative regulatory platform. Learn how LifeSphere Regulatory provides everything you need to drive transformative outcomes in regulatory today.
Learn more about our collaborative partnership with customers
Leverage the latest GenAI and LLM innovations powered by LifeSphere NavaX 
