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Regulatory

Coordinate readiness before the submission milestone.

Bring regulatory activity planning, content readiness, agency interactions, and externally produced submission evidence into a connected workspace.

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Regulatory work connected from planning through submission evidence.

SURAI Regulatory Workspace

Ask SURAI
  • Find and summarize regulatory context
  • Identify readiness gaps and follow-up
  • Context-aware support with human review

Plan

  • Regulatory Activities
  • Submission Planning

Prepare & Coordinate

  • Content & Evidence Readiness
  • Contributors, Responsibilities & Deadlines

Engage

  • Agency Requests & Correspondence
  • Commitments & Responses

Retain

  • Submission Archives & Reports
  • Receipts & Acknowledgements
Supporting capabilitiesRole Access & Document VersionsTasks, Notifications & Audit History

SURAI provides a connected workspace for coordinating regulatory activities, submission planning, content readiness, agency interactions, responsibilities, and retained evidence across the regulatory lifecycle.

  • Plan regulatory activities and submissions

    Organize regulatory objectives, submission plans, required content, contributors, milestones, dependencies, and deadlines.

  • Coordinate content and evidence readiness

    Track required contributions, supporting evidence, document gaps, responsibilities, and work that remains outstanding before external publishing.

  • Manage agency interactions and commitments

    Maintain agency requests, correspondence, responses, commitments, ownership, due dates, and follow-up in their regulatory context.

  • Retain submission evidence

    Connect externally produced submission archives, reports, receipts, and acknowledgements with the activities and decisions they support.

  • Use AI with human oversight

    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.

  • Maintain ownership and traceability

    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

See the work in context.

A demonstration can follow a scenario like this, using sample data and the agreed functionality.

  1. 01. Define the activity

    Identify the submission objective, required content, contributors, and deadlines.

  2. 02. Assess readiness

    Review missing documents and evidence, then assign follow-up to the responsible contributors.

  3. 03. Coordinate responses

    Track agency requests, correspondence, and commitments in their regulatory context.

  4. 04. Retain submission evidence

    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

Explore how SURAI could fit your team.

Discuss your workflows and arrange a focused demonstration.

Request a demonstration