Sovereign AI for regulated science.
Reign for Life Sciences gives pharma, biotech and CROs a sovereign AI platform built for the vocabulary of GxP and 21 CFR Part 11. Train and run foundation models on your own data, inside your perimeter.
Foundation models can transform discovery. If you can deploy them under GxP.
Pharma and biotech leaders want LLMs writing protocols, agents triaging clinical data, and multimodal models reading slides. But none of that ships if your QA group can't validate it, your regulator can't audit it, or your IRB can't trace it. Public AI services aren't an option for IND data, PHI, or proprietary biology.
21 CFR Part 11 and EU Annex 11 require validated, attributable, contemporaneous, and accurate records of every system interaction. Including AI.
Foundation models produce non-deterministic outputs that traditional CSV/CSA frameworks weren't designed to validate.
PHI, IND data, and trade-secret biology cannot be sent to public LLM endpoints under HIPAA, GDPR, or your CDA obligations.
Internal MLOps platforms can't keep up with the cadence of new open-weight models from NVIDIA, Mistral, and Anthropic.
FDA's AI/ML guidance and the EU AI Act both pull clinical-decision-support AI into high-risk regimes.
Provenance for training sets, fine-tunes, prompts and outputs is what an inspection works from.
How iTmethods serves life sciences
Reign. Governed AI. Outcomes assured. Built for regulated enterprises that need the trust, runtime, and sovereign infrastructure to move at AI speed.
Sovereign by Construction
Run open-weight foundation models inside your environment. VPC, on-prem, or fully air-gapped. PHI, IND data, and biology never leave.
GxP-Aligned Audit Trail
Every prompt, response, training run, and fine-tune is logged with a 21 CFR Part 11-aligned, tamper-evident record.
Multimodal & Bio-Aware
Reign for Life Sciences supports protein, genomics and imaging models, not just text, with the right hardware and evaluation harnesses.
Reign-Powered Governance
Reign Gateway records each governed model and tool call today. Reign Assurance is being designed to turn those records into evidence your QA group and IRB can review.
Validated Workflows
Pre-built validation packages for clinical document drafting, regulatory writing, and lab data analysis. Accelerate your CSV/CSA cycle.
NVIDIA Inception Partner
Reign for Life Sciences is built with NVIDIA's bio-AI stack and runs validated reference architectures for healthcare and life sciences.
Products purpose-built for your stack
Pick what you need. Run it where you need it. Govern everything from one control plane.
Built for the regulations you actually face
Evidence is generated automatically. Auditors, regulators, and internal risk teams get what they need. Without your engineers writing another spreadsheet.
Electronic records and signatures for AI workflows, with attributable, contemporaneous, and tamper-evident logs.
Validation-ready architectures for AI used in development, lab, manufacturing, and clinical settings.
PHI never leaves your perimeter. BAA-friendly deployment models, including air-gapped.
Data residency and lawful-basis tracking in Reign Gateway today; explanation of a recorded decision is being designed into Reign Assurance.
Clinical decision support, diagnostic AI, and HR-screening models classified, documented, and conformity-ready.
Aligned with FDA's PCCP and good machine learning practice for software as a medical device.
Where teams in life sciences are starting
Regulatory & medical writing
Models drafting CSRs, protocols and INDs, with the provenance of each draft recorded for QA and inspection review.
Clinical operations agents
Governed agents that triage adverse events, normalize lab data, and summarize EDC outputs without ever exposing PHI.
Discovery & translational AI
Run protein, genomics, and imaging foundation models on your private compute. Sovereign, fast, and reproducible.
Pharmacovigilance copilots
Reign Gateway governs the prompts in scope and records them; the assurance and reliance judgments stay with your safety and quality experts.
Validation-ready developer platform
Reign Ops gives your scientific software engineers a SOC 2 / GxP-deployable CI/CD platform. Without the multi-year build.
CRO / sponsor data exchange
Sovereign deployment lets sponsors and CROs collaborate on AI workflows without commingling regulated data.
Become a design partner. Help define sovereign AI for regulated science.
We are building Reign for Life Sciences with a small cohort of pharma, biotech, and CRO leaders. Cohort members shape the validation packages, the GxP-aligned controls, and the multimodal model support. And get early access in their environment.
Outcomes we are targeting with the cohort
These are the outcomes the design partner cohort is working toward together. Not historical claims. Co-developed targets, transparently tracked.
Scientists & developers
Foundation models on your data, in your environment. Without the procurement, security, or QA marathon.
- Open-weight LLM, protein, and imaging models under one runtime
- Cursor, Copilot, and internal MCP servers governed by Reign
- Reproducible workflows with versioned prompts, datasets, and outputs
QA, regulatory, & IRB
Workflows and evidence built for EU GMP Annex 11 vocabulary, packaged for inspection and audit review.
- 21 CFR Part 11 / EU Annex 11 aligned audit trails
- Pre-built validation packages for medical writing and lab workflows
- Provenance for every training set, fine-tune, prompt, and output
CSO, CMO, CIO, and the board
A defensible position in front of the FDA, EMA, and your investors. And AI moving fast enough to actually matter for the pipeline.
- Air-gapped sovereign deployment for the most sensitive programs
- Joint reference architectures with NVIDIA's bio-AI stack
- Co-developed roadmap aligned with discovery, clinical, and regulatory needs
“Pharma cannot ship AI workflows that QA cannot validate, IRB cannot trace, or the inspector cannot audit. The cohort is being built to make those three things possible at the same time as discovery moves at AI speed.”
iTmethods Design Partner Cohort thesis
Frequently asked questions
- Which life-sciences regulations does Reign address?
- Reign Assurance is being designed for the vocabulary of FDA PCCP, 21 CFR Part 11, GxP and the EU AI Act. Mapping to a specific IND, NDA, BLA or PCCP submission is joint work with your regulatory affairs function and counsel.
- What is Reign for Life Sciences?
- It is the life-sciences configuration of Reign, not a separate product. The same four motions apply: Reign Ops operates the toolchain and is available today, Reign Factory is in beta and being productized, Reign Gateway governs model access and is available today, and Reign Assurance prepares the record and is in co-design development. What changes for life sciences is the framework vocabulary and the evidence a validation process expects.
- Does Reign support 21 CFR Part 11 e-signatures and audit trails?
- Reign records what was requested, what policy allowed, what was returned and who approved it, as the work happens rather than assembled afterwards. Whether that satisfies 21 CFR Part 11 for a given system is your validation team's determination, not a claim we make on this page.
- Can Reign run in air-gapped environments for sensitive programs?
- Yes. Where it runs is a deployment property: hosted dedicated, customer cloud (AWS / Azure / GCP), or fully air-gapped. The most sensitive discovery and clinical programs deploy air-gapped without losing the governance Spine.
- How does Reign help with FDA PCCP for AI/ML medical devices?
- Reign Assurance is being designed to hold an approved-model registry with versioning, predetermined change-control records, drift detection and validation checks, and to record each change with its supporting evidence. The submission judgment stays with your regulatory affairs experts.
- How do life-sciences organizations engage Reign today?
- Reign is being hardened with a small set of Tier 1 design partners through 2026. Ninety-day pilots. Reign Ops (Managed Runtime + Modern DevOps) runs in production today. Life-sciences organizations interested in Reign apply at /pilot.