Q BRIDGE AI · A family of AI-first FDA submission platforms

Two FDA submission platforms. One audit chain. Built for regulatory consulting firms that ship.

INDBridge for IND drug + biologic submissions. DeviceBridge for 510(k) device submissions. Each platform compresses an 18-month, multi-vendor regulatory program into a single AI-driven submission engine. Specialist Claude agents draft every artifact. Named regulatory leads e-sign at nine human gates. A tamper-evident hash-chained audit records every action. Built for 21 CFR Part 11. Validated to GAMP-5 Category 5. AWS healthcare-grade migration committed for the first 30 days of implementation (HIPAA BAA, Aurora Multi-AZ, ECS Fargate); production currently runs on Vercel + Fly.io + Supabase, all SOC 2 Type II sub-processors.

standalone products live today

signed human-in-the-loop gates per submission

100%

actions captured in the hash-chained audit

3 more

products in build · NDA · BLA · ANDA · 2027 GA

Designed for US regulatory consulting firms, sponsors, and contract regulatory partners

21 CFR Part 11FDA CDRH · CDER · CBERICH M11 · M4GAMP-5 Cat 5HIPAA BAAAWS healthcare-grade

Two products. One platform foundation.

Each Q BRIDGE product is a standalone vertical.

INDBridge and DeviceBridge are sold as separate commercial deals — separate MSAs, separate commercial agreements, separate brand identities. A single regulatory consulting firm can white-label one or both. Customers running both products on the same sponsor (e.g., combination products, companion diagnostics) get one federated audit chain spanning drug + device regimes.

FDA IND · CDER + CBER · drugs & biologics

you are here

INDBridge

From molecule to 30-day clock.

INDBridge is the only AI-first IND submission platform that ships day-one compliance with the 2024-2026 FDA wave: FDORA DEPICT, Project Optimus, ICH M11 CeSHarP, iPSP, AI/ML PCCP, RACE Act. eCTD packaging for FDA Forms 1571 / 1572 / 3674 / 3454 / 3455 / 3500A / 356h. FDA ESG submission via AS2 + S/MIME + WebTrader.

Full CMC, nonclinical, clinical, ICH M11 protocol authoring
30-rule Refuse-to-File analyzer pre-submission
180-day clinical-hold cliff alerting with CEO escalation
7-day SUSAR + 15-day serious-unexpected reporting (21 CFR 312.32)
Cross-product audit chain to DeviceBridge for companion diagnostics

Inside INDBridge ↓

FDA 510(k) · CDRH · devices

separate gateway

DeviceBridge

From device concept to K-number.

DeviceBridge compresses an 18-month multi-vendor 510(k) program into a single AI-driven submission platform. Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, 513(g), Pre-Sub (Q-Sub). MDUFA FY2026 user fee handling. CDRH Portal upload via Pega-resilient attended automation.

26 eSTAR sections drafted by specialist Claude agents
FDA's own RTA / Technical Screening checklist runs pre-upload
180-day AI Request cliff tracked T-60/30/14/7/3/1
Form FDA 3601 generation + FRBNY payment reconciliation
Cross-product audit chain to INDBridge for combination products

Inside DeviceBridge ↓

INDBridge · inside the platform

Seven phases. Nine signed gates. One audit chain. For drugs & biologics.

INDBridge replaces the traditional first-IND consulting engagement (BioBoston, FDA Group, NIH SEED). 14 specialist Claude agents draft CMC, nonclinical, clinical, and eCTD modules in parallel. Built day-one for the 2024-2026 FDA mandate wave (DEPICT, Optimus, iPSP, ICH M11, AI/ML PCCP, RACE Act). 7-day SUSAR + 15-day serious-unexpected reporting per 21 CFR 312.32 with audit-chain attestation.

01
Drug candidate intake · Pre-IND meeting prep
Drug candidate data (small molecule, biologic, gene therapy, cell therapy) classified by INTENDED route and indication. Pre-IND Meeting Request agent drafts FDA Q-list, prepares CMC briefing, and assembles the meeting package. CBER vs CDER routing locked at Gate 1.
Gate 1 · RA Lead
02
CMC Module 3 · ICH Q-series
CMC agents draft drug substance + drug product modules per ICH Q1-Q13. Specification, manufacturing process, batch analysis, stability, container closure. ICH Q5A-Q5E for biologics (viral safety, cell substrate, comparability). CMC SME countersigns.
Gate 3 · CMC review
03
Nonclinical Module 4 · 2024-2026 mandate coverage
Pharmacology, ADME, toxicology drafts. iPSP (Initial Pediatric Study Plan) per FDASIA §505B. Carcinogenicity, repro-tox, genotoxicity per ICH M3(R2) / S-series. Nonclinical Lead approves.
Gate 4 · Nonclinical
04
Clinical protocol · ICH M11 CeSHarP · DCT support
ICH M11 CeSHarP machine-readable protocol authoring. DEPICT (FDORA §3601) Diversity Action Plan for Phase 3. Project Optimus dose-optimization design for oncology Phase 2+. Decentralized Clinical Trial (DCT) elements per May 2023 guidance. RACE Act pediatric oncology assessment.
Gate 5 · Clinical
05
Investigator Brochure · Forms · eCTD assembly
Investigator Brochure drafted from CMC + nonclinical + clinical. FDA Forms 1571 (IND application), 1572 (statement of investigator), 3674 (ClinicalTrials.gov certification), 3454/3455 (financial disclosure), 3500A (MedWatch), 356h (cover sheet) filled via pikepdf AcroForm + ZIP packaging.
Gate 6 · Section bundle
06
RTF Validator · eCTD validation · FDA ESG submission
30-rule Refuse-to-File Analyzer runs pre-submission (per FDA Sept 2017 guidance). eCTD package validated against FDA technical conformance. FDA ESG submission via AS2 + S/MIME envelope + WebTrader receipt poll. Per-Sub-customer S/MIME cert provisioning in AWS Secrets Manager.
Gate 7 + Gate 9
07
30-day clock · Annual reports · IND Safety Reports
30-day FDA review clock tracked from FDA ESG MDN receipt. Clinical Hold cliff alerting at T-60/30/14/7/3/1 with 6-tier CEO escalation. Annual Reports per 312.33, Protocol Amendments per 312.30, IND Safety Reports per 312.32 (7-day SUSAR + 15-day serious-unexpected) — all in same audit chain.
Post-submission

DeviceBridge · separate gateway at db.atdot.app

Six phases. Nine signed gates. One audit chain. For devices.

DeviceBridge never advances on its own. Every milestone is a named human's signed decision, bound to the artifact hash they reviewed. 14 specialist Claude agents work in parallel; one Orchestrator agent dispatches and owns the audit trail. The platform replaces a fragmented consulting + DIY-tooling workflow per first 510(k) program.

01
Intake & classification
Device data enters once. The Pathway Classifier returns Class I/II/III, product code, regulation, and pathway. The CBER routing branch fires early for blood, cellular therapy, or vaccine products — a misroute caught at Gate 1 saves the 60 days a wrong-center submission would cost.
Gate 1 · RA Lead
02
Predicate discovery & substantial equivalence
The Predicate Finder queries the live FDA 510(k) and De Novo databases — no fabricated K-numbers. The SE Analyst builds the side-by-side comparison table and drafts the FDA's five-decision-point narrative. RA and QA countersign.
Gate 2 + Gate 4
03
Test plan & section authoring
Bench, biocompatibility, software, EMC, animal, clinical, human factors — each scoped against FDA's recognized consensus standards. Section authors draft all 26 eSTAR sections in parallel. RA and Eng Lead countersign the plan; RA approves the section bundle.
Gate 5 + Gate 6
04
eSTAR assembly & Refuse-to-Accept pre-check
The eSTAR Assembler fills the FDA's dynamic Acrobat template. The RTA Validator runs the FDA's own acceptance checklist deterministically. Total-size and per-attachment limits are enforced before upload, not after a CDRH refusal.
Gate 7 · RA + QA
05
User fee & submission
Form FDA 3601 PIN generated. ACH/eCheck payment reconciled with the FRBNY confirmation. CDRH Portal upload via attended automation. CBER ESG path for biologics. USB-courier fallback for over-4-GB submissions.
Gate 8 + Gate 9
06
Review clock & AI Request response
Day 7 / 15 / 60 / 90 milestones and the 180-day AI cliff tracked from inbound FDA correspondence. K-number captured automatically from the Acknowledgement Letter. Post-clearance: registration, listing, MDR, and Letter-to-File workflows live in the same audit chain.
Post-submission

Roadmap · 2027

Three more standalone products in the pipeline.

Each future product is its own commercial deal under its own white-label agreement. Existing Customers receive a non-binding 60-day pre-GA notification right with early-adopter terms for existing Customers. The underlying platform infrastructure (hash-chained audit, 9-Gate HITL, FDA ESG, eCTD pikepdf adapter, mock-FDA fixture, AWS healthcare-grade hosting) is shared across all products.

GA target · Q1 2027

GenericBridge

FDA ANDA generics + 505(b)(2) hybrid drugs

Orange Book RLD lookup · Paragraph IV certifications · BE study design · 180-day exclusivity tracking

GA target · Q2 2027

NDABridge

FDA NDA new-drug marketing approval (505(b)(1) + 505(b)(2))

Integrated safety + efficacy summaries · BIMO · REMS · Risk Management · Labeling · post-marketing

GA target · Q4 2027

BLABridge

FDA BLA biologics + 351(k) biosimilars

ICH Q5A-Q5E · cell line + fermentation + purification + characterization · comparability · immunogenicity

Shared platform foundation

Every Q BRIDGE product runs on the same six pillars.

The product brands (INDBridge, DeviceBridge, and the 2027 cohort) sit on top of one shared platform. This is why we can ship multiple products without compounding engineering cost — and why your Customer's audit chain is the same whether they're filing an IND, a 510(k), or a combination submission later.

AI-first drafting

14 specialist Claude agents per product.

Pathway classifier, predicate / RLD finder, SE / RTF analyst, device or drug-candidate writer, IFU / labeling author, test plan architect, biocompatibility / nonclinical analyst, software documentation generator, cybersecurity §524B (devices) or DEPICT / Optimus / iPSP (drugs) author, eSTAR or eCTD assembler, submission orchestrator. One Orchestrator agent dispatches, owns state, owns the audit trail.

9-Gate human-in-the-loop

No agent submits to FDA without nine named signatures.

Each gate is a signed PDF manifest binding the signer + timestamp + artifact hash + intent string. Multi-signer on critical gates (G4 SE / Clinical, G7 eSTAR / eCTD assembly). WebAuthn 2FA mandatory on every signature. Sign-offs are immutable in the hash-chained audit ledger.

Source-of-truth doctrine

Agents refuse to emit ungrounded claims.

Predicate citations, product codes, K-numbers, consensus-standard references, ICH guidance citations — all looked up against live FDA / ICH databases at submission time. The query, the result hash, and the result snapshot are logged. An agent that can't ground a claim refuses to emit it.

Mock-FDA fixture

Rehearse the submission before you pay the user fee.

DeviceBridge: mock CDRH Portal at :7510. INDBridge: mock FDA ESG (AS2 + WebTrader) at :7610. Both fixtures emulate the FDA's response surface (Acknowledgement Letter, Hold Letter, AI Letter, MDN receipt). Your Sub-customer's first real submission is their second; the first is the rehearsal.

180-day cliff alerting

Zero missed cliffs across the platform.

AI Request (devices), Hold Letter, RTA Hold, Technical Screening Hold all auto-delete the submission at day 181. Clinical Hold (drugs) has its own 30-day clock. INDBridge adds 7-day SUSAR + 15-day serious-unexpected reporting per 21 CFR 312.32. T-60/30/14/7/3/1 alerts with CEO SMS escalation.

Cross-product audit chain

One federated audit for combination products.

A Sub-customer running both DeviceBridge and INDBridge (combination products, companion diagnostics, drug-device combinations) gets one cross-product audit chain. The chain is hash-linked across products; verifier walks both ledgers and confirms integrity. First-of-kind in the regulatory-affairs SaaS market.

Regulatory coverage

Built for the FDA. Ready for the rest of the world.

The platform's data model is multi-jurisdiction by design. The same artifacts that satisfy an IND (drugs) or a 510(k) (devices) feed an EMA Clinical Trial Application or a CE-mark technical file — without re-keying. Each Q BRIDGE product is independently validated to GAMP-5 Category 5.

United States · FDA / CDER + CBER · INDBridge scope

21 CFR Part 312 (IND), Part 314 (NDA — future NDABridge), Part 600/601 (BLA — future BLABridge), Part 314.94 (ANDA — future GenericBridge). All eCTD-based. All FDA ESG AS2 + WebTrader.

21 CFR Part 312 — Investigational New Drug application
21 CFR 312.32 — IND Safety Reports (7-day SUSAR + 15-day)
21 CFR 312.33 — Annual Reports · 312.30 — Protocol Amendments
FDORA §3601 DEPICT — Diversity Action Plans for Phase 3
FDASIA §505B iPSP — Initial Pediatric Study Plan
Project Optimus oncology dose-optimization (Phase 2+)
ICH M11 CeSHarP machine-readable clinical protocol
FDA AI/ML PCCP — Predetermined Change Control Plans

United States · FDA / CDRH · DeviceBridge scope

21 CFR Parts 807 (Premarket Notification), 820 (QSR / QMSR transition Feb 2026), 803 (MDR), 821 (Tracking), 822 (Post-market surveillance) and the FDA's electronic submission template (eSTAR).

21 CFR Part 11 — electronic records & signatures
21 CFR Part 807 — Premarket Notification 510(k)
21 CFR Part 820 → QMSR transition Feb 2026 (ISO 13485 alignment)
FDA Cybersecurity §524B (premarket cyber for connected devices)
MDUFA V FY2026 user-fee handling — Form FDA 3601 + SBD
CDRH Portal Pega-resilient RPA · CBER ESG fallback

International readiness · both products

The same source-of-truth data model supports parallel international filings. Predicate equivalence (devices) or CTD modules (drugs) translate to EMA, PMDA, Health Canada, TGA, ANVISA submission packs without re-keying.

EU CTR / EMA — clinical trial application (INDBridge)
EU MDR 2017/745 — Annex II technical documentation (DeviceBridge)
ICH M4 CTD — common technical document
ISO 13485 — QMS alignment (DeviceBridge)
ISO 14971 — risk management (both)
PMDA / HSA / TGA / Health Canada / ANVISA / COFEPRIS readiness

Software validation · GAMP-5 Category 5

Each Q BRIDGE product is itself developed and validated as a Category 5 (custom, regulatory-impact) system. URS → FS → DS, traceability matrix, IQ/OQ/PQ scripts, signed CI commits, required code review on main. AWS Audit Manager continuously collects HIPAA / SOC 2 / NIST 800-53 evidence.

URS / FS / DS authored and version-controlled per product
Traceability matrix — every requirement → at least one test
IQ / OQ / PQ scripts re-run on every release (AMC obligation)
Signed CI commits; required code review on main; no skipping hooks
AWS Audit Manager continuous evidence collection
Quarterly deviation reports; annual revalidation

Security & privacy

Designed for the questions a regulator and a CISO ask.

Personal data, patient data, and regulatory artifacts share a tenant boundary and an audit boundary. Nothing crosses it without a signed record. Current production stack: Vercel + Fly + Supabase (all SOC 2 Type II); AWS healthcare-grade migration is committed for the first 30 days of Customer-1 implementation per docs/AUDIT-2026-05-19.md and 08-IMPLEMENTATION-PLAN.md.

Hosting · current state + AWS roadmap

Vercel + Fly + Supabase today · AWS healthcare-grade by Day 30.

Production today runs on three SOC 2 Type II sub-processors: Vercel (web edge), Fly.io (FastAPI + agents), and Supabase Pro (Postgres with Row-Level Security on every tenant table). At Customer-1 signing the platform migrates to AWS healthcare-grade in Implementation Plan Phase 0-3 (Days 1-30): Aurora PostgreSQL Multi-AZ us-east-1 primary / us-east-2 backup / us-west-2 DR, ECS Fargate, S3 with KMS CMKs + Object Lock Compliance mode, AWS Shield Advanced, AWS Audit Manager. AWS BAA executed at Day 30 milestone, not Day 0.

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). Per-tenant SSO via SAML/OIDC.

Data protection

Encrypted at rest. Encrypted in transit. Tenant-isolated.

AES-256 at rest via AWS KMS customer-managed keys, TLS 1.3 in transit, per-tenant Row-Level Security at the Aurora tier. Per-Sub-customer S/MIME certs (INDBridge FDA ESG) in AWS Secrets Manager. No Customer data is used to train models.

Personal data

GDPR / HIPAA / 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. Sub-processors documented per region. HIPAA BAA scope covers Customer + all Sub-customer clinical-trial data.

Audit & forensics

Tamper-evident, not just append-only.

Every action appends to a SHA-256 hash-chained ledger anchored to a genesis event. AWS S3 Object Lock in Compliance mode strengthens 21 CFR Part 11 §11.10(e). A standalone verifier walks the chain on demand.

Operations

SOC 2 Type II Q4 2026. ISO 27001 Q4 2026. Penetration test Q3 2026.

Sentry error reporting, OpenTelemetry traces, structured logs retained per policy. RPO 0 / RTO 60s on Aurora Multi-AZ. Multi-region warm standby optional Year 2 (Aurora Global Database). Quarterly DR tabletop. Access reviews on a fixed cadence.

See it for yourself

Sign in to the Q BRIDGE platform of your choice.

INDBridge and DeviceBridge are separate application gateways. Pick the platform that matches your sponsor's pipeline. If you need to white-label one or both for your consulting firm, our team will walk you through the live platform on your engagement volume and your compliance footprint.

INDBridge · IND drugs & biologicsSign in to INDBridge →ind.atdot.app · CDER + CBER · IND · Pre-IND · ICH M11 DeviceBridge · 510(k) devicesSign in to DeviceBridge →db.atdot.app · CDRH · 510(k) · De Novo · 513(g) · MDUFA

Talk to our team

Contact

Considering Q BRIDGE for your regulatory consulting firm?

Whether you're running your first IND, your fortieth 510(k), or both — Vamsy will walk you through the live platform on your sponsor base, your engagement volume, and your compliance footprint. White-label agreements sign in 21 days.

Tell us a little about your firm and we'll be in touch within one business day.

INDBridge · Live at ind.atdot.app · FDA IND

DeviceBridge · Live at db.atdot.app · FDA 510(k)

GenericBridge · NDABridge · BLABridge · 2027 GA