The problem isn't that regulations are complicated. The problem is that they're scattered.
For AI teams: EU AI Act obligations live in one place, GDPR in another, DORA somewhere else, SR 11-7 in a Fed guidance document last updated years ago. None of it maps to your actual models by default — that work falls on your team.
For biopharma teams: FDA guidance lives on CDER. ICH harmonisation lives somewhere else. EMA opinions are separate. CMC expectations for your modality aren't written down anywhere — they're inferred from approval history.
Beacon pulls it all together, maps it to your portfolio, and tells you exactly what applies to you. We're pre-launch and accepting a small number of pilot partners to validate this in real workflows.
Apply
Takes 2 minutes. Tell us about your team and the regulatory problem you're solving.
Onboard
We configure your workspace and walk you through the platform for your specific use case.
Shape the Product
Two short sessions over the pilot. Your input directly influences what we build next.
Regulatory AI Compliance
Automated obligation mapping across EU AI Act, GDPR, HIPAA, DORA, SR 11-7, and more — with clause-level change detection and a learning flywheel that improves per customer.
Who this is for
- Compliance and legal teams at AI-native companies, SaaS platforms, and financial institutions managing obligations that are specific to how AI systems work — not just general information security certifications like SOC 2
- Financial institutions and banks running model risk management programs under OCC 2011-12 or SR 11-7
- AI product and engineering teams that need to know which of their models, features, and pipelines trigger EU AI Act, GDPR, or DORA obligations — before the legal team asks
- Organizations currently tracking multi-framework AI obligations in spreadsheets or with consultants, who need a system that learns from their team's decisions rather than requiring manual updates every time a regulation changes
Not the right fit if you're managing a single product in one jurisdiction, or if you're looking for a document management or regulatory writing tool. Also not the right fit if your primary need is SOC 2 or ISO 27001 certification automation — Vanta and Drata are excellent at that and we don't try to compete there.
What you get
- 90 days of full platform access at no cost
- Direct input into the roadmap — your use case shapes what we build next
- Dedicated onboarding and a named point of contact on the Beacon team
- Ask regulatory questions in natural language via Claude Desktop (MCP integration included)
What we ask
- 2–3 structured feedback sessions over the pilot period
- Share one real compliance workflow or AI system for the platform to map
Biopharma Intelligence
CMC data infrastructure for early-stage biotech teams — the ones too small for Veeva, too serious for spreadsheets. Sequence analysis, SOT sync, automated analytical QC, and IND-ready documentation across 6 therapeutic modalities.
Who this is for
- CMC scientists and regulatory leads at seed-to-Series B biotechs working on biologics, gene therapy, mRNA, or biosimilar programs — preparing their first IND without a 50-person regulatory team
- Regulatory consultancies and CROs who manage IND prep workflows for multiple biotech clients simultaneously — and need infrastructure that scales across engagements without rebuilding from scratch each time
- Companies managing multiple biologic modalities who need obligation mapping tied to CTD structure and development phase
Not the right fit if your pipeline is purely small molecule with no biologics, advanced therapy, or biosimilar components. Also not the right fit if you're at a company large enough for Veeva Vault or Cortellis — those platforms are excellent for your scale. Beacon is built for what comes before that.
What you get
- 90 days of full platform access at no cost
- Direct influence on FDA corpus depth, modality coverage, and CMC output formats
- A dedicated regulatory intelligence briefing tailored to your pipeline and molecule class
- Ask biopharma regulatory questions in natural language via Claude Desktop (MCP integration included)
What we ask
- 2–3 structured feedback sessions over the pilot period
- Reference at least one active or recent program as a workflow benchmark
Pilot spots are limited
We're keeping the cohort small intentionally — so every pilot partner gets direct access to the founding team and meaningful influence on the product. If you're working in regulatory compliance or IND preparation and want to move faster with better tooling, we'd like to hear from you.
Get in touch