Unify operations for easier authoring and assembly
³Ô¹Ï±¬ÁÏ Submissions is the leading content management application used to plan, author, review, and approve regulatory documents. It provides full enterprise capabilities for creation, version control, approval, and real-time co-authoring of all submission-related documents.
With content planning capabilities, users can build a submission outline and automatically match documents to the outline. They can also build and publish clinical and non-clinical reports using report level content plans.
Dashboards and reports allow submission managers to track the status of each document in real time.
A real-time regulatory information feed, through our partnership with leading analytics provider Redica, turns data into actionable regulatory intelligence in the context of your portfolio.
80%
submission tasks eliminated or simplified
200+
hours saved on approval and renewal reporting
15x
more submissions handled with streamlined processes
³Ô¹Ï±¬ÁÏ Submissions Impact
Gain visibility
Track progress through actionable reports and dashboards.Accelerate time to market
Automate multiple authoring and assembly tasks.Align global teams
Coordinate affiliate submissions and health authority interactions.
See ³Ô¹Ï±¬ÁÏ Submissions in action
Customer Success
Medtechs ensure compliance with ³Ô¹Ï±¬ÁÏ RIM
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See how six leading GenAI models stack up against human experts on typical regulatory affairs tasks
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Medtech thought leaders share how to reposition regulatory and quality as strategic partners to drive business value
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Leading medtechs are using RIM solutions to scale efforts, accelerate timelines, and maintain compliance
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³Ô¹Ï±¬ÁÏ Submissions Features Brief
