Design Partner Program — Now Accepting ApplicationsLearn More

    The Fortress Family by iTmethods

    BioCompute

    AI governance for regulated life sciences.

    Govern every AI interaction from LLM call to regulatory submission. Sovereign. Auditable. FDA-ready.

    NVIDIA InceptionMaRS MomentumFDA 21 CFR Part 11Native intoDNA STRIDE® DDR

    90-Day Proof of Value: $25K — validate with your own data before scaling

    Validated & Supported By
    intoDNA / AstraZeneca8 of 10 Top Global Pharma
    NVIDIA InceptionAI Startup Program
    MaRS MomentumScaling to $100M+

    Full-Stack AI Governance for Life Sciences

    Five Products. One Platform.

    Built on Reign — the enterprise AI governance platform by iTmethods. Every layer fully managed with a dedicated FDE.

    Output

    Evidence Books

    Per-project, per-regime deliverables

    Pre-built regulatory templates mapped to specific frameworks. Each Evidence Book is a submission-ready package tailored to your project and jurisdiction.

    FDA 21 CFR 11EU AI ActGxP / GMPHIPAAISO 42001NIST AI RMF

    Orchestration

    Compliance Manager

    Orchestrates compliance lifecycle

    Orchestrates the entire evidence collection, review, and submission process. From raw data through regulatory filing — managed end-to-end.

    Multi-stage review workflows
    Role-based approvals
    Submission deadline tracking
    Cross-team coordination

    Foundation

    AI Gateway

    What AI models can say and see

    Controls LLM interactions with prompt guardrails, PII redaction, content filtering, and intelligent model routing across 100+ providers.

    Prompt injection defense
    Real-time PII detection
    100+ LLM routing
    Cost tracking

    Control Plane

    Agentic Hub

    What AI agents can do

    Enterprise MCP governance. As AI agents call external tools (97M+ monthly SDK downloads), the Agentic Hub ensures every interaction is verified and traced.

    Tool signature verification
    Rug-pull defense
    Agent chain tracing
    Pre-execution approvals

    Compliance Core

    Evidence Engine

    Immutable compliance proof

    Cryptographic audit trails, electronic signatures, and tamper-proof records. FDA 21 CFR Part 11 native. Every action logged with full attribution.

    Immutable audit trails
    Electronic signatures
    Cryptographic integrity
    21 CFR Part 11

    Fully Managed · Dedicated FDE

    SaaSDedicatedCustomer CloudAir-Gapped

    AWS · Azure · GCP · NVIDIA DGX · Oracle · On-Premise

    ⎊Powered by Reign

    The Governance Gap

    Why Now

    The life sciences AI governance gap is urgent and growing. Every month without governance infrastructure increases compliance debt.

    $2.1M
    Avg cost of enterprise AI incident (IBM 2025)
    73%
    Of life sciences firms lack AI governance
    97M+
    Monthly MCP SDK downloads — new surface
    Aug 2
    EU AI Act enforcement — high-risk

    60–80% of manual compliance evidence collection can be automated — saving $200K–$500K/yr per organization. BioCompute delivers 8–15x ROI.

    Bio Intelligence Suite

    Life Sciences Bio Intelligence

    The AI Foundation governs. The Bio Intelligence discovers. Multi-modal data ingestion, biomarker discovery, predictive regulatory intelligence — all running on sovereign, governed infrastructure.

    Multi-Modal Ingestion

    Q4 2026

    FASTQ, BAM, DICOM, mzML, HL7 FHIR + 50 formats. Native intoDNA STRIDE® integration.

    Biomarker Discovery

    Q4 2026

    AI-powered cell counting, quantification, MoA correlation, and patient stratification signals.

    Regulatory Intelligence

    Q1 2027

    Gap analysis, submission readiness scoring, regulatory change monitoring, cross-jurisdiction mapping.

    Therapeutic Modules

    Q1 2027

    Pre-configured workflows for Oncology (P0), Neurodegeneration, Immunology, and more.

    Deployment Options

    Deploy Your Way. We Manage Everything.

    Every option includes a Forward Deployed Engineer who embeds with your team to own outcomes

    ← Fastest to deployMaximum sovereignty →

    SaaS

    Multi-tenant with logical isolation. Fastest time-to-value for teams starting their AI governance journey.

    SHARED INFRADATA ISOLATEDAUTO-SCALE
    Most Popular

    Dedicated

    Single-tenant on BioCompute-managed infrastructure. Your own compute, your own encryption keys.

    SINGLE TENANTBYOKSOC 2

    Customer Cloud

    Runs inside your VPC on your cloud account. Data never leaves your boundary. Full FDA closed-system status.

    YOUR VPCYOUR ACCOUNTCLOSED SYSTEM

    Air-Gapped

    Zero internet connectivity. On-premise hardware with sovereign compute. For classified and defense-grade workloads.

    ZERO EGRESSON-PREM GPUFIPS 140-2

    Fully Managed · FDEs Accelerate Outcomes

    AWS·Azure·GCP·NVIDIA DGX·Oracle·On-Premise
    Low-Risk Entry Point

    Validate Before You Scale

    90-Day Proof of Value — $25K

    Test BioCompute with your own data, your own workflows, your own regulatory requirements. Every engagement includes a dedicated Forward Deployed Engineer. No risk. Real evidence.

    90 Days
    From kickoff to validated evidence
    Dedicated FDE
    Embedded with your team
    Real Evidence
    Your data, your compliance proof
    NVIDIA InceptionMaRS Momentum
    Now Accepting Design Partners

    Design Partner Program

    Shape the platform that governs AI and generates FDA-ready evidence — from LLM call to regulatory submission.

    Native Integration: intoDNA STRIDE®—their most sensitive single-molecule DDR assay—runs natively on BioCompute OS.

    Building the trust layer for the next frontier of precision medicine.

    Platform Capability Tracks

    AI Foundation

    AI Gateway, Agentic Hub, and Compliance Manager — govern every LLM call, agent action, and regulatory workflow from day one.

    Bio Intelligence

    Evidence Engine and Evidence Books — transform wet-lab data into FDA-ready evidence packages across 6+ regulatory regimes.

    Deployment Flexibility

    SaaS, Dedicated, Customer Cloud, or Air-Gapped — every tier fully managed with a Forward Deployed Engineer embedded in your team.

    Partner Benefits

    Dedicated FDE Team

    A Forward Deployed Engineer embeds with your team to own outcomes — not just support tickets

    AI Foundation + Bio Intelligence

    Full-stack access to both platform tiers before general availability

    Deployment Flexibility

    Choose your deployment model — from multi-tenant SaaS to air-gapped sovereign installations

    Founding Partner Pricing

    Locked-in pricing for the duration of your commitment — significant savings vs. GA

    Applications reviewed within 48 hours · NDA-protected process · Includes dedicated FDE

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