Startup Studio 2026 — Top 100 of 700+
Hyperagent Founding 500From AI Innovation to Regulatory Approval. Automated.
Beacon is the regulatory intelligence layer for companies deploying AI systems and for biopharma teams preparing for IND readiness. Two distinct modules, one underlying platform intelligence.
Built for AI Companies
SAP Startup Studio 2026
Top 100 of 700+ AI Startups
Hyperagent Founding 500
Backed by Airtable · Howie Liu
Google for Startups
Cloud Program Member
MongoDB for Startups
Strategic Infrastructure Partner
21 CFR Part 11 Compliant
FDA-Grade Audit Trails
EU AI Act Ready
Aug 2026 Enforcement
6 Therapeutic Modalities
FDA · EMA · ICH Coverage
Enterprise-Ready
SOC 2 · ISO 27001 Frameworks
SAP Startup Studio 2026
Top 100 of 700+ AI Startups
Hyperagent Founding 500
Backed by Airtable · Howie Liu
Google for Startups
Cloud Program Member
MongoDB for Startups
Strategic Infrastructure Partner
21 CFR Part 11 Compliant
FDA-Grade Audit Trails
EU AI Act Ready
Aug 2026 Enforcement
6 Therapeutic Modalities
FDA · EMA · ICH Coverage
Enterprise-Ready
SOC 2 · ISO 27001 Frameworks
0+
Regulations covered
0
Therapeutic modalities
0+
FDA approval packages ingested
The Problem
The Regulatory Bottleneck
AI can design therapeutics in hours and deploy enterprise features in days. But proving regulatory compliance still takes 12–18 months of manual processes, consultants, and spreadsheets.
12–18mo
Average compliance timeline
vs. days to build the AI system
€35M
Max EU AI Act fine
or 7% of global annual revenue
#1
Cause of IND delays
Data integrity failures in biopharma
Platform
One Platform. Two Applications.
Each module addresses a distinct high-stakes regulatory hurdle using Beacon's underlying system of intelligence.
BeaconLabs
AI Compliance
The regulatory intelligence layer for AI governance teams. Translates evolving regulations (EU AI Act, GDPR, DORA) into actionable obligations, sitting upstream of GRC workflows like Credo AI and OneTrust.
BeaconOS
IND Readiness
The IND Readiness Platform connecting regulatory expectations, evidence generation, and CMC execution. Understand regulator expectations, identify gaps, and stay on track.
Underlying Intelligence
Built to Translate Complexity into Action.
Whether it's an EU AI Act clause change or a new FDA Chemistry Review pattern, Beacon's core system of intelligence detects the delta, determines applicability, and updates your obligations automatically.
Determine Applicability
Map Obligations
Detect Changes
Update GRC Stack
Monitor
Clause-level change detection across all regulations and FDA approval packages in real time.
Automate
AI agents map requirements, validate data, classify risk, and surface only what matters to your team.
Submit
Audit-ready packages, evidence exports, and submission-ready documentation on demand.
Learn
A learning flywheel that compounds: every team decision improves obligation accuracy over time.
SAP Startup Studio 2026
Top 100 of 700+ AI Startups Globally
21 CFR Part 11 Compliant
EU AI Act Articles 9–15
FDA-Grade Data Integrity
Enterprise-Ready Infrastructure
Ready to Automate Your Compliance?
Bridge the gap between regulatory change and operational reality. Implement the intelligence layer for AI governance and Biopharma IND prep.