G1RA Lead
Pathway & routing
Drug class, intended route and indication, and the CDER-vs-CBER routing decision. Biologics, gene therapy, and cell therapy are routed to CBER here — a routing error fixed at Gate 1 avoids a wrong-center detour later.
INDBridge · How it works
An IND pipeline that never advances on its own.
Specialist Claude agents draft every artifact in an IND submission — CMC, nonclinical, clinical, and the eCTD modules. A named regulatory lead e-signs at nine human Gates. A tamper-evident hash chain records every step. The result is speed without a loss of rigor — first-submission timelines measured in weeks, with each milestone still signed by a person and verifiable by an inspector.
9
human-in-the-loop gates per submission
14
specialist agents drafting in parallel
30-day
FDA review clock tracked from MDN receipt
100%
agent actions logged with tool-use traces
Every capability below is framed by what it does for a Regulatory Affairs and QA lead
CDER + CBER · eCTDFDA ESGRTF pre-check180-day cliff
Human-in-the-loop
Nine gates. Nine named signatures.
The platform halts at each gate until a named regulatory lead e-signs with WebAuthn 2FA. Each sign-off produces a manifest binding signer, timestamp, intent, and the SHA-256 of the exact artifact reviewed — and lands in the hash-chained audit. Why it matters: an FDA decision is only as defensible as the human accountability behind it, and these nine gates are that accountability, recorded mechanically.
G2RA Lead
Pre-IND prep
The FDA Q-list, CMC briefing, and Pre-IND meeting package, when a Pre-IND meeting is used to align with the agency before filing.
G3CMC SME
CMC (Module 3)
Drug substance and drug product modules per ICH Q-series — specification, manufacturing process, batch analysis, stability, container closure; ICH Q5A-Q5E for biologics.
G4Nonclinical Lead
Nonclinical (Module 4)
Pharmacology, ADME, and toxicology, with the iPSP and the ICH M3(R2) / S-series assessments. A safety-bearing gate.
G5Clinical Lead
Clinical protocol
The ICH M11 machine-readable protocol, the DEPICT Diversity Action Plan, Project Optimus dose-optimization for oncology, and DCT elements.
G6RA Lead
Section bundle
The Investigator Brochure and FDA forms (1571, 1572, 3674, 3454/3455, 3500A, 356h) reviewed together before assembly.
G7RA + QA
eCTD assembly
A passing Refuse-to-File pre-check and an eCTD package validated against FDA technical conformance before anything is transmitted.
G8RA Lead
Submission readiness
Per-Sub-customer S/MIME cert provisioning confirmed and the FDA ESG envelope prepared, reconciled before release.
G9CEO / authorized signatory
Release
The final go / no-go to transmit over the FDA ESG (AS2 + S/MIME + WebTrader). No agent ever submits to FDA without this explicit signed release.
The specialist-agent pipeline
Fourteen specialists. One orchestrator. One audit trail.
Each agent is narrow and accountable. A single Orchestrator agent dispatches them, owns submission state, and owns the audit trail. Agents draft and analyze; humans decide at the gates.
- 01
Classify & route
The candidate is classified by intended route and indication — small molecule, biologic, gene therapy, cell therapy — and routed to CDER or CBER, with the Pre-IND meeting package prepared.
Why it matters · RA gets a defensible starting point and an early routing catch.
- 02
Author CMC & nonclinical
CMC agents draft the Module 3 drug-substance and drug-product modules per ICH Q-series; nonclinical agents draft pharmacology, ADME, and toxicology per the ICH M3(R2) / S-series, with the iPSP.
Why it matters · CMC and nonclinical SMEs review complete drafts with gap analysis.
- 03
Author the clinical protocol
The clinical agent drafts the ICH M11 machine-readable protocol with the DEPICT Diversity Action Plan, Project Optimus dose optimization, and the Investigator Brochure assembled from CMC, nonclinical, and clinical inputs.
Why it matters · The clinical lead sees a protocol built day-one for the 2024-2026 FDA wave.
- 04
Assemble & pre-validate
FDA forms are filled, the eCTD package is built, and the Refuse-to-File analyzer runs FDA's RTF rules deterministically with eCTD technical-conformance validation before transmission.
Why it matters · QA sees the RTF verdict before the submission is transmitted.
- 05
Submit & track
The Submission Orchestrator transmits over the FDA ESG (AS2 + S/MIME + WebTrader), polls the receipt, and tracks the 30-day review clock from the MDN.
Why it matters · RA gets the 30-day clock and cliff alerts from real FDA acknowledgements.
First-of-kind capabilities
What makes the rigor mechanical, not aspirational.
These are the capabilities a skeptical RA or QA reviewer should probe hardest. Each is stated as a concrete mechanism and what it buys the regulatory team.
Source-of-truth doctrine
Agents refuse to emit ungrounded claims.
Regulatory citations, ICH guidance references, and product-specific facts are looked up against live FDA / ICH sources at draft time. The query, the result hash, and the result snapshot are logged. An agent that cannot ground a claim refuses to emit it.
Why it matters · No fabricated regulatory citation can ever enter a submission.
AI provenance
A full tool-use trace per agent run.
Every agent run records its tool calls, the sources it grounded against, and token telemetry. The reasoning path is reconstructable after the fact.
Why it matters · An inspector can reconstruct exactly what each agent did and why.
Mock-FDA rehearsal
Rehearse the whole submission before going live.
A mock FDA ESG (AS2 + WebTrader) emulates the agency's response surface — the MDN and acknowledgement receipts. The first real submission is effectively the second; the first run is a full rehearsal.
Why it matters · The team meets failure modes in rehearsal, not on the real clock.
Refuse-to-File analyzer
FDA's RTF rules, run deterministically.
The Refuse-to-File analyzer runs FDA's RTF rules before transmission, alongside eCTD technical-conformance validation. The verdict is deterministic, not a model guess.
Why it matters · QA predicts a clean filing before the package is transmitted.
eCTD assembly
An open-source production path.
FDA forms are filled and the eCTD package is built and validated, with per-Sub-customer S/MIME certs provisioned for the FDA ESG envelope.
Why it matters · RA sees a conformant eCTD package, not a hand-wave.
180-day cliff alerting
Multi-channel escalation, T-60 to T-1.
The Clinical Hold has its own 30-day clock; INDBridge also tracks 7-day SUSAR and 15-day serious-unexpected reporting per 21 CFR 312.32. Alerts fire at T-60 / 30 / 14 / 7 / 3 / 1 with escalation, so a deadline is never silently missed.
Why it matters · The most expensive failures — a missed hold response or safety report — are engineered out.
See it on a live workspace
Walk the pipeline end to end with us.
We will run a candidate through classification, CMC and nonclinical authoring, the ICH M11 protocol, the Refuse-to-File pre-check, and a mock-FDA rehearsal — and show you the audit chain and tool-use traces behind every step.