Compass
Ariadne Suite · Regulatory Affairs

Regulatory submissions,
tracked end to end.

Ariadne Compass manages your entire regulatory portfolio — from first CTA to post-approval variations. One pipeline, every territory, every team member, no spreadsheets.

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Full Regulatory Portfolio
Track every live application across all regulatory pathways and territories — MAA, CTA, 510(k), PMA, IND, IVDR, CE Mark — in a single dashboard.
  • EU EMA, UK MHRA, and US FDA pathways
  • Status tracking from preparation through to approval
  • Reference number, territory, and type all searchable
  • Filter by status, territory, deadline, or assignee
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Document Checklist Engine
Each application type auto-generates the required document checklist. Track what is complete, what is pending, and what is blocking submission.
  • Pre-built checklists for MAA, CTA, 510(k), IND and more
  • Per-document upload and version tracking
  • Completion percentage live on every application card
  • Source Data Verification (SDV) log per document
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Deadline and Timeline Alerts
Never miss a response window or renewal date. Compass calculates days-to-deadline for every live application and surfaces urgent items first.
  • Colour-coded urgency: overdue, critical (7d), warning (30d)
  • Automatic overdue flags with notification
  • Submission target date tracking with planned milestones
  • Timeline view per application with key date history
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Team Task Management
Assign tasks to regulatory affairs team members. Track open and completed actions per application. No separate project management tool required.
  • Task assignment with assignee, due date, and priority
  • Application-linked tasks with completion tracking
  • Team view across all open tasks with overdue flags
  • Internal correspondence log per application
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Guided Pathway Selector
Not sure which regulatory route to take? The Pathways tool guides you through the decision logic — based on product type, indication, and target market.
  • MAA vs CTA vs 510(k) vs PMA decision tree
  • IVDR and CE Mark route selection
  • Conditional logic based on product class and territory
  • Outputs a recommended strategy with key steps
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Sculptor Integration
Forms and regulatory data captured in Sculptor can be imported directly into Compass applications — connecting your clinical data to your regulatory submissions.
  • Direct import from Sculptor form builder
  • PDF and Word document attachment support
  • Form version recorded with every import
  • Links clinical evidence directly to application dossier
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Status
All Applications 0
Preparation 0
Submitted 0
Under Review 0
Approved 0
On Hold 0
Rejected 0
Withdrawn 0
Territory
All Territories
🇬🇧 UK MHRA
🇪🇺 EU EMA
🇺🇸 US FDA
🌐 Other
Deadline Alert
🔴 <30 days 0
🟡 30–90 days 0
Clear filter
0
Total
0
Active
0
Approved
0
Urgent
All Applications
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Welcome to Compass
Sign in or enter demo mode to manage your regulatory applications.