FDA IND · End-to-end
From preclinical candidate to FDA-active IND.
16 specialist Claude agents draft every IND artifact. Nine human-signed gates anchor each milestone to the artifact hash. A tamper-evident audit chain records every action. Built for 21 CFR Part 11 and ICH E6(R3).
Platform
Every IND artifact, drafted, hashed, and signed.
The platform owns the full IND lifecycle — from drug-candidate intake through FDA submission and the 30-day review clock. Specialist agents read sponsor-supplied source data; named regulatory leads e-sign each milestone with WebAuthn; nothing crosses a gate without a manifest hash.
Intake & classification
IND Type Classifier
Agent 1 classifies Commercial / Investigator / Emergency Use / Treatment / Expanded Access per 21 CFR 312, and routes CDER vs CBER. Devices bounce to QB510K.
Pre-IND meeting
Type B briefing
Agent 2 drafts the meeting request, questions, and briefing book per FDA's 'Formal Meetings with FDA' guidance. Outcomes integrate before Gate 2.
CMC · Module 3
Drug substance + product
Agent 3 drafts §3.2.S and §3.2.P per ICH Q1/Q2/Q3/Q6 + 21 CFR 211 cGMP. Stability tables, manufacturing process, specifications.
Nonclinical · Module 4
GLP-aware drafting
Agent 4 maps studies to ICH S1–S11, drafts §2.6 + §4.2, flags non-GLP studies before they hit Gate 4.
Clinical · Module 5
Protocol + SAP + IB
Agents 5–7 draft dose-escalation protocols, ICH E9(R1) estimands, and ICH E6(R3) §8.3 Investigator's Brochures.
Assembly · ESG
eCTD v3.2.2 + ESG
Agents 8–10 fill Forms 1571/1572/3674, assemble the five-module eCTD, validate structurally, and submit via Playwright RPA.
How it works
Six phases. Nine signed gates. One audit chain.
The platform never advances on its own. Every milestone is a named human's signed decision, bound to the artifact hash they reviewed.
Intake & classification
Drug-candidate intake. The IND Type Classifier returns ind_type, fda_center, and review division. CBER routing for biologics fires early — a misroute caught at Gate 1 saves the 60 days a wrong-center submission would cost.
Pre-IND meeting
Agent 2 drafts the Type B meeting request, list of questions, and briefing document. FDA responses thread into downstream artifacts — a stopping rule FDA asks for in Q3 shows up in the protocol automatically.
CMC + Nonclinical drafting
Agents 3 and 4 draft Module 3 and Module 4 in parallel. QC Lead reviews CMC, Tox Lead reviews nonclinical. Blocking GLP issues flagged before sign-off.
Clinical protocol + IB
Agents 5 and 6 draft the Phase 1/2/3 protocol with SAP and the Investigator's Brochure. Medical Monitor + RA Lead countersign both.
eCTD assembly + Forms
Agent 9 builds the eCTD v3.2.2 package; structural validation runs. Forms 1571/1572/3674 generated. Sponsor signatory signs Form 1571 with WebAuthn at Gate 8.
ESG submission + 30-day clock
Agent 10 submits via FDA's Electronic Submissions Gateway. The 30-day review clock starts at FDA receipt. Agents 11–14 handle the lifecycle: clock tracking, safety reports, annual reports, amendments.
Regulatory coverage
Built for the FDA. Aligned with ICH.
The data model is multi-jurisdiction by design. The same artifacts that satisfy an FDA IND feed an EMA CTA, an MHRA CTA, or a PMDA Phase 1 notification — without re-keying.
United States — FDA / CDER / CBER
- 21 CFR Part 312 — Investigational New Drug
- 21 CFR Part 11 — electronic records & signatures
- 21 CFR Part 56 — IRBs
- 21 CFR Part 50 — informed consent
- 21 CFR Part 58 — Good Laboratory Practice
- 21 CFR Part 211 — current Good Manufacturing Practice
- FDA ESG — Electronic Submissions Gateway
- FDA AA Section 801 — ClinicalTrials.gov registration
ICH-aligned for multi-region submissions
- ICH M4 — CTD organization
- ICH E6(R3) — Good Clinical Practice
- ICH E9(R1) — Estimands & sensitivity analyses
- ICH Q1A(R2) through Q6 — CMC
- ICH S1–S11 — Nonclinical
- ICH M3(R2) — Nonclinical safety for clinical trials
- EMA CTA (Voluntary Harmonisation) compatible
- PMDA / MHRA / Health Canada artifact reuse
Software validation — GAMP-5 Category 5
- URS → FS → DS → traceability matrix
- IQ / OQ / PQ executed against the live deployment
- Validation report retained per release
- Every requirement maps to at least one executed test
- Audit trail per 21 CFR 11.10(e) — append-only, hash-chained
- GxP impact assessment per release
Lifecycle reporting
- 7-day IND safety report — 21 CFR 312.32(c)(2)
- 15-day IND safety report — 21 CFR 312.32(c)(1)
- Annual report — 21 CFR 312.33
- Protocol amendment — 21 CFR 312.30
- Information amendment — 21 CFR 312.31
- Clinical hold response — 21 CFR 312.42
Security & compliance posture
Designed for the questions a regulator and a CISO ask.
Personal data, sponsor data, and regulatory artifacts share a tenant boundary and an audit boundary. Nothing crosses without a signed record.
Identity
Two-factor on every signature.
Login is bearer-JWT with mandatory FIDO2 / WebAuthn second factor when enrolled. Every Gate signature additionally requires the e-signature PIN AND a fresh WebAuthn assertion bound to the artifact hash — replay-resistant per 21 CFR Part 11 §11.200(a). Roaming security keys and platform biometrics both supported.
Data protection
Encrypted at rest. Encrypted in transit. Tenant-isolated.
AES-256 at rest, TLS 1.2+ in transit, per-tenant Row-Level Security at the database tier as a defense-in-depth layer. Service-role credentials never leave the backend. No sponsor data is used to train models.
Personal data
HIPAA / GDPR / LFPDPPP-aware data handling.
Personal and patient identifiers are scoped to the records that require them, with retention boundaries and deletion paths. Data Subject Access Requests are first-class operations, not a manual export. Sub-processors and data-processing agreements are documented per region.
Audit & forensics
Tamper-evident, not just append-only.
Every action — login, signature, agent run, document mutation — appends to a SHA-256 hash-chained ledger anchored to a genesis event. A standalone verifier walks the chain on demand. If any row is altered, the verifier reports exactly which link broke.
Source-of-truth grounding
No hallucinated regulatory citations.
Agent citations resolve against live FDA guidance pages and the eCFR. The query and the result hash are logged. An agent that cannot ground a claim refuses to emit it — the open-items list flags what needs human research.
Operations
SOC 2–aligned controls. Live observability.
Sentry error reporting, OpenTelemetry traces to a managed backend, structured logs retained per policy. RPO / RTO targets defined and tested. Quarterly DR tabletop. Access reviews on a fixed cadence.
Why teams switch
An IND program, redesigned around the bottleneck.
The slow part of an IND isn't the FDA review — it's the months spent producing the submission. RegBridge removes the drafting bottleneck without removing the regulatory rigor.
Time to submission
Weeks, not quarters.
The classic IND cadence is 12–18 months of drafting, redlines, vendor handoffs, and section-by-section assembly. RegBridge parallelises every section and ships an eCTD-ready package in weeks. Pathway, CMC, nonclinical, protocol, and IB drafts move concurrently.
Risk on the review clock
Catch the deficiency before the FDA does.
Deterministic eCTD validation pre-checks run the FDA's own acceptance criteria against your submission before you upload. The 30-day review clock is tracked in real time with T-21 / 14 / 7 / 3 / 0 alerts. Misrouted CDER/CBER products are caught at Gate 1.
Audit readiness
Every action is on the record.
Hash-chained audit ledger, e-signatures bound to artifact hashes, signature manifests for every milestone. When an FDA inspector or an internal auditor asks who approved what, when, and against which version — the answer is one query away.
See it for yourself
Stand up an IND program and walk it through its first submission.
Pick a sponsor name, name an RA Lead, and the platform seeds a tenant for you. Every action from that point is a real 21 CFR Part 11 event in your own audit chain — signed, hashed, retained.
Contact
Have an IND coming up?
Whether you're submitting your first IND or your fortieth, our team will walk you through the live platform on your drug substance, your nonclinical package, and your compliance footprint.
- vamsy@qbridge.ai
- Company
- Q BRIDGE AI
- Platform
- Live · regbridge.atdot.app