Plan
- Regulatory Activities
- Submission Planning
Coordinate readiness before the submission milestone.
Bring regulatory activity planning, content readiness, agency interactions, and externally produced submission evidence into a connected workspace.
Request a demonstrationSURAI provides a connected workspace for coordinating regulatory activities, submission planning, content readiness, agency interactions, responsibilities, and retained evidence across the regulatory lifecycle.
Organize regulatory objectives, submission plans, required content, contributors, milestones, dependencies, and deadlines.
Track required contributions, supporting evidence, document gaps, responsibilities, and work that remains outstanding before external publishing.
Maintain agency requests, correspondence, responses, commitments, ownership, due dates, and follow-up in their regulatory context.
Connect externally produced submission archives, reports, receipts, and acknowledgements with the activities and decisions they support.
Ask SURAI to find and summarize regulatory information, identify readiness gaps, and highlight follow-up requiring attention—with authorized users reviewing the resulting information and actions.
Link documents, versions, tasks, notifications, responsibilities, decisions, and audit history to the regulatory activities they support.
Together, these capabilities help regulatory teams coordinate submission readiness and follow-up while maintaining visibility from initial planning through retained submission evidence.
EXAMPLE WALKTHROUGH
A demonstration can follow a scenario like this, using sample data and the agreed functionality.
Identify the submission objective, required content, contributors, and deadlines.
Review missing documents and evidence, then assign follow-up to the responsible contributors.
Track agency requests, correspondence, and commitments in their regulatory context.
Link externally produced archives, reports, receipts, and acknowledgements to the activity.
Regulatory is in development. The scope is planning, coordination, and evidence tracking; publishing and transmission to health authorities take place outside SURAI.
LET’S START WITH YOUR NEEDS
Discuss your workflows and arrange a focused demonstration.