Services / Regulatory & Pharma AI
Regulatory & Pharma AIRegulatory work, drafted fast and reviewed by experts.
Regulators now review with AI, and sponsors are still filing blind. We build and run workflows that draft, check and trace regulatory and validation documents before they go out.
Deliverables, not slideware.
- IND gap assessments with severity-ranked findings and the sources behind each one
- Drafting support for IND, clinical and validation documents
- Validation protocols and reports, with deterministic checks kept separate from AI reasoning
- Source tracing: every material statement links back to your data and public sources
- Documentation built for audit from the first draft (21 CFR Part 11-aware)
From first call to production.
Scope
The question you need answered and the review cycles included, agreed in writing.
Pilot on your documents
We prove the workflow on a real section before broader commitment.
Expert-reviewed delivery
Software drafts, experts decide. A regulatory or validation expert signs off before delivery.
Keep it current
Rule content is refreshed to stay current with evolving guidance.
See it in practice.
MedNova IND Gap Assessment
A source-traced IND gap assessment platform that finds missing and inconsistent content before the FDA does, with an expert reviewing every finding.
Live demonstration (demo data)Read case study →AI-enabled validation documentation for a global bioprocessing leader
Report generation for validation documentation, measured against the client's own golden output, with a reproducible and traceable approach.
DeliveredRead case study →ICH and FDA protocol validation system
A protocol validation workspace that checks clinical protocol content against ICH and FDA expectations and shows the reasoning behind each check.
Live demonstration (login required)Read case study →RegWrite Hub: executive regulatory intelligence
An executive-level workspace for regulatory writing and intelligence, giving leaders a clear view of where regulatory work stands.
Live demonstrationRead case study →Good to know
Do experts review the work?
Yes. Software drafts, experts decide. In our regulatory work, an expert reviews every finding before it reaches you, and every statement is linked back to its source.
How is pricing set?
Every engagement is scoped in writing and priced after a scoping call. There are no seats or licenses; you pay for the deliverable, and strategy is included in the engagement.
Where does the system run, and who sees our data?
On your infrastructure: AWS, Azure or GCP, or on premise by arrangement. Access is role-based and activity is logged. We are happy to sign an NDA before you share anything.
Can we see examples of your work?
Yes. See the portfolio for case studies and demonstrations. Client names are anonymized, and additional project details and professional references may be provided upon request, subject to confidentiality and prior approval.
Know where you stand
before you build.
Tell us about your AI initiative or your next filing. We will tell you what a scoped engagement would cover and how it would be priced.