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Regulatory Submission Management and Publishing

Accelerate regulatory compliance with streamlined submissions and publishing activities.

Accelerate regulatory compliance with streamlined submissions and publishing.


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.

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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.

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Submission Reuse

Compile global submissions to use as the basis for national submissions.

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Document Propagation

Readily move documents from global to local submission dossiers.

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Submission Automation

Assisted compilation of submissions into predefined submission outlines.


Resources for Your Regulatory Journey

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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.

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