IND-Ready in Weeks, Not Months.
Beacon is CMC data infrastructure built for early-stage biotech teams — the ones too small for Veeva, too serious for spreadsheets. Real FDA Chemistry Review patterns, automated analytical QC, and submission-ready documentation. All in one workspace.
The Problem
The Speed Gap Between AI Biology and Regulatory Reality
AI systems design therapeutics in hours. Regulatory approval still takes 12–18 months. The bottleneck isn't biology — it's the compliance infrastructure that hasn't kept up.
AI designs in hours
Modern AI systems design therapeutics in hours. Regulatory approval still takes 12–18 months — mostly waiting for humans to figure out the requirements.
Guidance docs are stale
ICH guidance documents reflect what was approved in 2003. What FDA reviewers actually require today — buried in Chemistry Review decisions — is rarely codified anywhere.
No single source of truth
Requirements scattered across emails, spreadsheets, and consultants' heads. No traceable link from evidence to obligation. No auditable score.
Enterprise tools weren't built for you
Veeva starts at $200K/year. Cortellis is built for teams of 50+. Early-stage biotechs — 5 to 30 people, 6–18 months from IND — have been managing CMC compliance in spreadsheets and consultant emails. Beacon fills that gap.
Core Differentiator
The Only CMC Platform Built for Pre-IND Biotech Teams
Beacon's SOT (Source of Truth) Engine continuously ingests real FDA Chemistry Review documents — the actual NDA/BLA review decisions — across all 6 modalities. It extracts what reviewers actually found essential, beyond what ICH guidance documents say.
Every week, the SOT engine learns from new approvals and surfaces new obligations in your workspace automatically. Your requirements checklist reflects what's getting approved today — not what ICH guidance said in 2003.
- 50+ curated FDA approval packages ingested across all 6 modalities
- Only patterns seen in 3+ real approvals with ≥75% confidence surface in your workspace
- New FDA decisions trigger staleness alerts — one sync to stay current
- No competitor has this — static rules engines don't learn
Unlike Cortellis or Veeva, Beacon works on the analytical data layer — automating ICH QC checks and 21 CFR Part 11 audit trails that existing platforms don't touch.
How It Works
From Program to Submission-Ready: Step by Step
A structured workflow where every action traces to a regulatory obligation and every cleared blocker moves the needle on your IND score.
Add Your Therapy Program
Modality auto-detected from your sequence
Beacon identifies your therapeutic class and loads the curated IND framework for that modality — backed by real FDA approval data.
Run Sequence Analysis
AI maps your molecule to regulatory obligations
Your sequence is matched against FDA/ICH/EMA requirements specific to your modality. Every obligation traces back to a regulation clause — no black box.
Sync SOT
Pull latest FDA approval intelligence into your workspace
The Source of Truth engine ingests new FDA Chemistry Review documents. When it learns something new from recent approvals, one sync pulls those obligations into your checklist.
Clear Blockers in Requirements Explorer
Each cleared blocker raises your IND score
Upload evidence, link data to requirements, and resolve gaps. Your score has one source of truth — your own workspace. It goes up when your team acts.
Track Score to Submission-Ready
Auditable progress toward 100%
Monitor readiness across all requirement categories. When your score reaches submission threshold, every decision is documented, traceable, and regulator-ready.
Modality Coverage
6 Therapeutic Modalities. Real FDA Precedent Data.
Each modality has a curated IND framework backed by real FDA approval packages, not just guidance documents.
Peptide
FDA Peptide CMC · ICH Q6A
Monoclonal Antibody
FDA mAb CMC · ICH Q6B
Gene Therapy (AAV/CAR-T)
FDA OTAT · ICH Q5A
mRNA / LNP
FDA mRNA CMC · ICH Q6B
Recombinant Protein
ICH Q6B · FDA Bioavailability
Biosimilar
FDA 351(k) · ICH Q5E · EMA
IND Readiness Score
3 blockers remaining · mRNA/LNP program
How the Score Works
One Source of Truth. Your Workspace.
Your IND score has exactly one source of truth: your own workspace. It goes up when your team uploads evidence and clears blockers in the Requirements Explorer.
This makes the score trustworthy and auditable — a key 21 CFR Part 11 story. Every point increase traces to a specific human decision, an uploaded file, or a cleared regulatory obligation. No black box.
- Modality-aware weights: CAR-T judged differently than peptide
- Every obligation traces to a specific regulation clause
- Score changes are logged with timestamp and user, providing a full audit trail
- SOT sync adds requirements; your team clears them to raise the score
Who It's For
Built for Early-Stage Biotech — Not Big Pharma
Whether you're running experiments, building AI drug pipelines, or managing regulatory submissions, Beacon OS is the compliance layer underneath.
Features
Built for the Regulatory Complexity of AI-Driven Biotech
Sequence Analysis
Submit your molecule and Beacon auto-detects modality, then maps your sequence to every FDA/ICH/EMA obligation that applies — with full requirement provenance back to the specific regulation clause.
SOT Sync
Beacon continuously ingests real FDA Chemistry Review documents (NDA/BLA) across all 6 modalities. When new patterns are learned, your workspace flags a sync available — one click pulls the latest obligations into your checklist.
Requirements Explorer
Every requirement is a clearable blocker. Each cleared item directly raises your IND score. Requirements are tagged by agency (FDA/EMA/ICH), framework, and confidence tier — no black box, full traceability.
IND Readiness Score
A single, auditable score driven by your workspace. Goes up when your team uploads evidence and clears blockers in the Requirements Explorer. Modality-aware weights mean a CAR-T program is judged differently than a peptide IND.
Proteomics & Analytical Data Upload
Upload SEC, peptide mapping, and mass spectrometry datasets directly linked to specific IND requirements. SHA256 content-addressing makes every file tamper-proof. 21 CFR Part 11 audit trail on every upload.
Multi-Jurisdiction Requirement Tagging
Every requirement is tagged to FDA, EMA, or ICH — know exactly which agency needs what evidence and when. Avoid duplicating effort across submission packages.
Staleness Detection
Your workspace tells you when new FDA patterns have been learned and when a sync is needed. No manual monitoring — Beacon alerts you when your checklist may be out of date.
21 CFR Part 11 by Design
Electronic records, content-addressed storage (SHA256), access controls, and audit trails are built into every workflow — not bolted on as a compliance checkbox.
Pattern Confidence Tiers
Only high-confidence patterns (≥75% confidence, seen across 3+ real FDA approvals) surface in your workspace. Signal, not noise — backed by real approval data.
Is This Right for You?
Built for Early-Stage Biotech — Not Big Pharma
- 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.
Now Accepting Pilot Partners — Free Access for Early-Stage Biotech Teams
We're onboarding a select group of biotech and CRO teams to validate the platform in real IND workflows at no cost. Pilot partners get full access and direct influence on the product.
- 90 days of full platform access · no cost
- Regulatory intelligence briefing for your pipeline
- Ask biopharma regulatory questions in natural language via Claude Desktop (MCP integration included)
- Your modality and workflow shapes our roadmap
Pricing
Invest in Speed, Not Delays
Beacon is priced for early-stage biotech budgets — not enterprise contracts. No $200K annual commitments.
One IND submission delay costs more than a year of Beacon. Every month saved is a month closer to patients and revenue.
Ready to Close the Gap Between Your Science and Your First IND?
Every month of CMC delay is a month away from patients, revenue, and your next funding milestone. Most IND-stage biotechs spend 6 months on what Beacon automates in weeks.