Our Toolkits

Purpose-built tooling for the structured-data workflows regulatory teams now have to run day to day.

SmPC (SPC) Digitization

Challenge: SmPC (SPC) content lives as unstructured PDF text — locked away from search, reuse, and any downstream automation.

Use Case: SmPC Digitization extracts SmPC sections into validated, structured data — effectively the first version of ePI (electronic Product Information) a regulator can offer the public, healthcare professionals and hospitals, without needing an FDA-scale OpenFDA API programme to get there. The same structured dataset goes on to power Orphan Designation tracking and digitised procedural steps — RFIs and VCRs — downstream.

Structured extraction of SmPC sections into a consistent, queryable format
Version-to-version diffing to surface exactly what changed between updates
Validation against authority structure and content requirements

→ Try our Demo version

Controlled Vocabulary (CV) Management

Challenge: Authority-published controlled vocabularies update on their own release cycles, and keeping internal reference data aligned with all of them means constant manual reconciliation.

Use Case: CV Management brings every authority's code lists together in one place, so regulatory information management teams can track versions, compare equivalent lists across authorities, and map them against internal reference data without doing it by hand.

Centralized tracking of CV versions across authorities
Cross-authority comparison of equivalent code lists
Change alerts when an authority publishes a new CV version

→ Try our Demo version

Submission Lifecycle Tracker

Challenge: Submission status lives scattered across inboxes, spreadsheets and individual products, procedures and health authorities — with no single place to see where anything actually stands.

Use Case: Submission Lifecycle Tracker gives regulatory operations teams one consistent view of every submission's status, from initial build through health authority review to approval, with milestones, deadlines and an audit trail in one place.

Single view of submission status across products and authorities
Milestone and deadline tracking through the review lifecycle
Alerts when a submission needs action

→ Try our Demo version Coming soon…