Submission timelines tracked in Excel. Correspondence chased by email. Inspection anxiety every quarter because nobody is quite sure where the latest version of anything actually is.
Ariadne Compass is purpose-built regulatory affairs software — submission lifecycle tracking, dossier management, task boards, and AI-powered regulatory research, all in one platform. Built by a physician who has been on both sides of the regulatory conversation.
Compass replaces the spreadsheet patchwork with a single regulatory workspace — from initial filing plan to post-approval correspondence.
Track every submission from initial filing to approval — across multiple markets and authorities. Status dashboard gives your team a single source of truth.
Organise regulatory dossiers by module, section, and document. Version control ensures the right document reaches the right authority every time.
Log all regulatory correspondence with timestamps, deadlines, and response tracking. Never miss a query response deadline again.
Pre-built checklists for CTD modules, MAA sections, and IND components. Track completion progress in real time — know exactly what's missing before submission.
Kanban-style task board for regulatory projects. Assign tasks, set dependencies, and track milestones. Integrated calendar with authority meeting dates.
Paperclip AI answers regulatory questions from your document library and public guidance — EMA, FDA, MHRA. Get answers without leaving the platform.
Manage submissions across the EU, US, UK, and other markets in parallel. Per-market status, timelines, and correspondence — all in one view.
Generate inspection readiness reports on demand. Know your compliance status before the auditors arrive, not after.
All regulatory data stored securely with role-based access, full audit trail, and GDPR-compliant EU data residency. DPA available on request.
Book a 30-minute demo and we'll walk through your regulatory workflow — or open Compass directly and start tracking your first submission today.
£2,400/yr · up to 5 users · Sculptor + Compass bundle £4,200/yr (save £600)