Submission Management and Publishing

Accelerate regulatory compliance with streamlined submissions and publishing.

Submissions

Submissions consolidates submissions and publishing workflows in a single solution that makes it simple to create, compile, and publish submissions in any format.

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.

Features

Deliver real value with 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.