Plans for teams who sign the submission
Every plan includes the full engine. The tiers differ in volume, seats and integration, not in the rigour of the analysis.
Prices exclude VAT. SEPA Direct Debit accepted alongside card for EU customers.
Starter
For a solo regulatory lead or a very small team running a few submissions a year.
Billed monthly, cancel any time
- 3 projects per month, 10 documents each
- 3 analyses per month
- Full coverage ledger with grounding and refute pass
- CSV and PDF export after human review
- Standard guidance library
- Email support
Professional
For device companies and sponsor or CRO regulatory teams with a steady submission pipeline.
Billed monthly, cancel any time
- 20 projects per month, 50 documents each
- 20 analyses per month
- Everything in Starter
- API export for QMS and eTMF integration
- Up to 20 custom standards, 1,500 pages of your own guidance
- Priority email support
Enterprise
For larger regulatory teams, multi-product portfolios and stricter data-residency requirements.
- Capacity and seats sized to your team
- AI remediation assistant grounded in your analysis
- Single sign-on and dedicated customer success
- Self-hosted model option for data residency
- Service level agreement
The rigour is not a tier
Fail-visible coverage ledger
Every applicable requirement gets a verdict or an explicit manual-review flag.
Verbatim grounding
Citations are checked against the source text; ungrounded ones are downgraded and flagged.
Adversarial refute pass
A second pass challenges every finding and attaches counter-evidence for adjudication.
Human-review gate
Export is locked until a qualified person confirms the review. Recorded in the audit log.
Content alignment map
Cross-document consistency and version comparison, at no additional analysis cost.
Encryption and audit trail
AES-256-GCM at rest, MFA, role-based access, and a full audit log on every plan.
Compare plans
| Feature | Starter | Professional | Enterprise |
|---|---|---|---|
| Projects per month | 3 | 20 | Scoped with you Sized to your team |
| Documents per project | 10 | 50 | |
| Maximum file size | 25 MB | 50 MB | |
| Analyses per month | 3 | 20 | |
| Allocator seats | 2 | 8 | |
| Viewer seats | 3 | 10 | |
| Custom standards | No | 20 | |
| Custom guidance pages | No | 1,500 | |
| Export formats | CSV, PDF | CSV, PDF, API | |
| Single sign-on | No | No | |
| AI remediation assistant | No | No | |
| Regulatory change alerts | No | No | |
| Support | Priority email | Dedicated customer success |
Pricing questions
Can we change plans at any time?+
Yes. Upgrades and downgrades take effect immediately. If a downgrade leaves you over a seat or guidance cap, new invites and uploads pause until you are back within the limit. Existing data is never deleted automatically.
Why exactly one admin per organisation?+
Compliance accountability needs a single owning identity for billing, team changes and guidance uploads. Allocators do the day-to-day project work; viewers, such as external auditors or consultants, get read-only access.
How is Enterprise priced?+
Enterprise is sized to your team during onboarding: capacity, seats, custom guidance, the AI remediation assistant, single sign-on, a self-hosted model option and an SLA. Contact us and we will scope a package.
Which payment methods are accepted?+
Major credit and debit cards, and SEPA Direct Debit for customers based in the EU.
What guidance is pre-loaded?+
A curated library covering EU MDR and IVDR, FDA 21 CFR Parts 803 to 820, UK MDR, and the Japanese, Chinese and Australian frameworks, plus the verbatim clinical clause index for ICH E6(R3), E8(R1), E9, EU CTR 536/2014 and 21 CFR Parts 50, 54, 56 and 312. Professional and Enterprise customers can add their own guidance.
How is our data protected?+
Documents are encrypted at rest with AES-256-GCM and in transit with TLS. Platform staff cannot view customer document content. Controls are mapped to ISO 27001 and SOC 2 criteria, and we never share your documentation with third parties.