# Beacon — Regulatory Compliance Infrastructure

> Beacon is two AI-powered compliance products built for teams at the frontier of regulation: BeaconLabs for AI system compliance and Beacon OS for biopharma IND preparation.

## What Beacon Does

Beacon solves two distinct regulatory problems:

**BeaconLabs — AI System Compliance**
Maps your actual AI models, features, and pipelines to every regulatory obligation they trigger across 8 frameworks: EU AI Act, GDPR, HIPAA, DORA, SR 11-7, ISO 27001, HITRUST, and NIST CSF 2.0. Unlike Vanta or Drata (which automate security certifications), Beacon is built specifically for AI-system-aware compliance — EU AI Act risk classification, SR 11-7 model risk tiering, and DORA ICT obligations. A data flywheel learns from your team's accept/reject decisions, improving obligation relevance over time. Integrates bidirectionally with SAP GRC and ServiceNow IRM.

**Beacon OS — Biopharma IND Preparation**
CMC data infrastructure for early-stage biotech teams preparing their first IND. Built for companies too small for Veeva Vault, too serious for spreadsheets. The SOT (Source of Truth) Engine continuously ingests real FDA Chemistry Review documents (NDA/BLA approvals) across 6 therapeutic modalities and surfaces what FDA reviewers actually require — not just what ICH guidance documents say. Includes automated analytical QC, 21 CFR Part 11 audit trails, and an auditable IND Readiness Score.

## Who Beacon Is For

- AI product and engineering teams that need to know which of their models trigger EU AI Act, GDPR, or DORA obligations
- Compliance and legal teams at AI-native companies and financial institutions managing SR 11-7 or DORA
- Early-stage biotech teams (seed to Series B) preparing their first IND filing without a 50-person regulatory team
- Regulatory CROs and consultancies managing IND prep workflows across multiple biotech clients
- Financial institutions running model risk management programs under OCC 2011-12 or SR 11-7

## What Beacon Is NOT

- Not a SOC 2 or ISO 27001 certification tool (that's Vanta/Drata — they're excellent at that)
- Not a document management or regulatory writing platform
- Not designed for Big Pharma with Veeva Vault budgets
- Not a static rules engine — Beacon's flywheel learns and improves

## Key Differentiators

- Learning flywheel: every team decision trains the system, improving accuracy over time with no manual retraining
- AI-system-aware mapping: EU AI Act risk tiers, SR 11-7 tiering, DORA ICT obligations linked to your actual AI inventory
- SAP GRC + ServiceNow IRM bidirectional integration (entity-level, not just webhook)
- SOT Engine: real FDA Chemistry Review patterns from 50+ NDA/BLA approvals, not just guidance documents
- 21 CFR Part 11 compliant by design
- Recognized: SAP Startup Studio 2026 Top 100, Hyperagent Founding 500 (backed by Howie Liu, Airtable co-founder)

## Free Tools

- EU AI Act Readiness Assessment: https://eu-ai-act.beaconone.net
- IND Readiness Assessment: https://ind-readiness.beaconone.net

## Key Pages

- Homepage: https://www.beaconone.net
- AI Compliance: https://www.beaconone.net/ai-compliance
- Biopharma: https://www.beaconone.net/biopharma
- Solutions: https://www.beaconone.net/solutions
- Pilot Program: https://www.beaconone.net/plans
- Resources: https://www.beaconone.net/resources
- About: https://www.beaconone.net/about
- Contact: https://www.beaconone.net/contact

## Regulations Covered (AI Compliance)

EU AI Act (enforcement Aug 2026), GDPR, HIPAA, DORA (enforced Jan 2025), SR 11-7 (OCC model risk management), ISO 27001, HITRUST, NIST CSF 2.0

## Therapeutic Modalities Covered (Biopharma)

Peptide, Monoclonal Antibody (mAb), Gene Therapy (AAV/CAR-T), mRNA/LNP, Recombinant Protein, Biosimilar

## Company

Founded by Deakshanth Nandan Shetty (IIM Sirmaur MBA, CS Engineering, former TCS/VMware/iBaset).
Live at: https://www.beaconone.net
Contact: founder@beaconone.net