Portfolio

Work we can show.

Case studies and live demonstrations from our regulatory, healthcare and enterprise work. Client identities are anonymized.

6 projects

Regulatory AI · Product

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 →
Validation · Enterprise engagement

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 →
Regulatory AI · Product

From pre-IND to full IND: extending MedNova

Extending a pre-IND analysis tool into a full-IND gap analysis and generation workflow, with regulatory content supplied and reviewed by domain experts.

In developmentRead case study →
Regulatory AI · Demonstration

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 →
Regulatory AI · Demonstration

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 →
Agentic AI · Healthcare

SportsDoc AI: a conversational injury assistant

A conversational assistant for sports injuries, built in weekly develop-and-test cycles with a practising physician in the loop.

In clinical testing (not yet public)Read case study →

Additional project details and professional references may be provided upon request, subject to confidentiality and prior approval. Demonstrations use demo data and are not substitutes for regulatory review.

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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.