One system for the entire regulatory lifecycle.
Authoring, research, review, and submission — built around the way a regulatory team actually works, not a generic document workspace.
Six surfaces, one canvas. Move between them without losing context.
Author every section against live guidance.
Pick agency, device class, and submission type. REGARA™ scaffolds every required section and drafts against the most recent guidance for each.
Find the predicates a reviewer would accept.
Search the entire FDA 510(k) database by indication, technology, and substantial-equivalence proximity — not just keyword.
A single source of truth for every claim.
Marketing claims, technical claims, performance claims — versioned, source-anchored, and reusable across submissions and labeling.
The regulatory corpus, indexed daily.
FDA, EMA, PMDA, NMPA, MHRA, Health Canada, TGA — guidance documents, consensus standards, and warning letters, re-indexed every 24 hours.
Respond to agency questions in days, not weeks.
When deficiency letters arrive, REGARA™ assembles candidate responses with cited evidence. Your reviewers approve, edit, or reject — never start from scratch.
Reproduce any submission, on any date.
Every prompt, edit, citation, and approval is captured immutably. 21 CFR Part 11-aligned. Built for the inspection you haven't scheduled yet.
Agency, classification, and pathway analysis with precedent.
Surface the strongest predicate set with traceability for every comparison.
Section drafts against current guidance. Internal review queues, side-by-side diff against template.
Veeva, MasterControl, Greenlight Guru — version-locked and signature-ready.
eCTD / eSTAR export, agency-question workflows, deficiency tracking, periodic reports.
Citations are first-class. Always have been.
Every sentence REGARA™ writes is anchored to its source: the predicate, the guidance, the standard, the study. Click to inspect. Hover to preview. Edit to override — your override is captured too.
Guidance changes. So does your draft.
When the FDA updates a guidance you've cited, REGARA™ flags every affected section. One click to compare the language. One more to update — with the diff captured in the audit trail.
Lives where your team lives.
Bidirectional sync for documents, training, and change controls.
Approval routing and signature manifests pulled into REGARA™'s review queue.
For medical device companies — design history file and risk tooling integration.
Drop in where your team already drafts. Word round-tripping with citations preserved.
SSO, SCIM provisioning, and SAML group-based permissions.
Export-ready packaging for FDA, EMA, PMDA, and Health Canada.
Plug your clinical and quality data warehouses into the claims library.
Bring your own storage with customer-managed encryption keys.
Bring a submission. We'll show you the difference.
A 60-minute working session on a project of your choosing. Under NDA, on isolated infrastructure, with your team's reviewers in the room.