About 6 months
to prepare an IND today
Industries · Pharma & Life Sciences AI for pharma and life sciences —
AI for pharma and life sciences —
across the value chain.
Our lead industry. The same governed, source-traced approach from early R&D through regulatory, clinical, and validation — delivered as finished work, with experts in the loop.
Across the value chain
Where AI earns its place in life sciences.
Each stage links to the service that delivers it. Everything shares one foundation: retrieval with human review, deterministic checks kept separate from AI reasoning, and sources attached to every statement.
Stage
Drug development & R&D
Literature intelligence, evidence generation, and knowledge management over your internal and public sources.
Explore →
Stage
Regulatory
IND gap assessment, drafting support, and submission readiness — every statement source-traced and expert-reviewed.
Explore →
Stage
Clinical
Clinical summary reports, trial documentation, and patient-data review, traced back to the source tables and listings.
Explore →
Stage
Validation & quality
Protocol and report generation with 21 CFR Part 11-aware documentation and requirement-to-test traceability.
Explore →
Stage
Commercial (support)
Market access and MLR-adjacent documentation support, scoped to your controls.
Explore →
The context Regulators now review with AI.
Regulators now review with AI.
The economics of getting it right have changed.
FDA launched Elsa, its agency-wide AI tool, in June 2025, with agentic AI following in December. Getting a filing right the first time is worth more than it has ever been.
The status quo, in numbers Speed Cost Accuracy FDA AI, aka Elsa
Where life sciences stands today.
$51K–$300K
total to write and draft an IND
Nearly 100%
regulatory compliance of AI-drafted trial documents, up from 70–80% for a general-purpose chatbot
2025
FDA launched Elsa, its agency-wide AI tool, in June. Agentic AI followed in December.
Experience
Deep roots in regulated life sciences.
Experience in pharma & life sciences
Our team's individual experience spans large-cap pharmaceutical and biotechnology organizations across regulatory, clinical, and validation work.
Additional project details and professional references may be provided upon request, subject to confidentiality and prior approval.
Talk to us about your life sciences AI initiative.
Tell us what you are working on. We will tell you what a scoped engagement would cover and how it would be priced.