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eCTD sequence ops · Reg Ops / Publishing Manager

CuRE Consign

eCTD assembly + sequence lifecycle and dispatch to health-authority gateways.

Part of Regulatory

What it does

eCTD assembly + sequence lifecycle and dispatch to health-authority gateways. No re-keying at the publishing hand-off — Compend packages, Calculate outputs, and Consulate registration identifiers flow straight into sequences instead of being reassembled by hand.

Key capabilities

  • eCTD assembly + sequence lifecycle (new / replace / append / delete)
  • Technical + regional validation
  • External / CRO binary-artifact ingestion (Conduit-fed, SHA-256-verified, into the sequence assembly surface)
  • Dossier review + submission archive
  • Dispatch to HA gateways (FDA ESG, EMA CESP)
  • AI CTD auto-classification / granularization
  • Source→PDF/A rendering
  • Hyperlink / xref integrity validation
  • FDA eCTD 4.0 backbone

What sets it apart

  • No re-keying at the publishing hand-off — Compend packages, Calculate outputs, and Consulate registration identifiers flow straight into sequences instead of being reassembled by hand.
  • AI auto-classifies and granularizes documents into CTD slots, renders source content to submission-grade PDF/A, and blocks a sequence on broken hyperlinks.
  • Legacy eCTD import, external/CRO binary-artifact ingestion (SHA-256-verified on read via the Conduit front door, ADR-PLT-040), eCTD 4.0, grounded dossier QA, continuous publishing, and global content plans run on one governed pipeline.
  • Sequence lifecycle (new / replace / append / delete) is first-class, not a folder-naming convention.
  • One governed pipeline for every sequence — not a per-sequence vendor work order.
  • IND assembly and maintenance (Module 2.4 / 2.6, IND-readiness) extend eCTD publishing upstream to first-in-human, per the Translational bundle (ADR-PLT-100).
CuRE Consign · eCTD sequence lifecycle
Live demo — synthetic data, runs in your browser

Assemble an eCTD dossier from its lifecycle, not its folders

An eCTD submission is a series of sequences, and each sequence files lifecycle operations — new, replace, append, delete — against prior leaves. Step through the sequences of a synthetic IND and watch Consign fold that operation graph into the "current view": the leaves actually in force. Inject a lifecycle fault and watch the integrity validator catch it before dispatch.

A synthetic US IND — ravucizumab (VELT-042) — filed as a series of eCTD sequences. Real ICH/FDA CTD paths; every operation is a lifecycle edge, not a file copy.

The lifecycle graph as a clean reg-ops publisher would file it — no findings.

In force
8
effective leaves
Superseded
2
by replace
Deleted
2
by delete
Validation
Pass
no errors

eCTD lifecycle tree · filed through seq 0002

In forceSupersededDeleted
Module 1 · Regional / administrative
Cover letternewIn force
us/us-regional/cover/cover-letter.pdf
FDA Form 1571newDeleted
us/us-regional/forms/fda-1571.pdf
FDA Form 1571 (withdrawn)deleteTombstone
us/us-regional/forms/fda-1571.pdf
→ operates on L-0000-1571 · filed seq 0002
Module 2 · CTD summaries
Clinical summarynewSuperseded
24-clin-summary/clinical-summary.pdf
Clinical summary (rev. 2)replaceIn force
24-clin-summary/clinical-summary.pdf
→ operates on L-0000-clinsum · filed seq 0002
Module 3 · Quality
Drug product (3.2.P)newSuperseded
32-body-data/32p-drug-product/drug-product.pdf
Drug product (3.2.P, rev. 2)replaceIn force
32-body-data/32p-drug-product/drug-product.pdf
→ operates on L-0000-drugprod · filed seq 0002
Drug substance — stability supplementappendIn force
32-body-data/32s-drug-substance/drug-substance-stability.pdf
→ operates on L-0000-drugsub · filed seq 0002
Drug substance (3.2.S)newIn force
32-body-data/32s-drug-substance/drug-substance.pdf
Module 5 · Clinical study reports
Protocol amendment 01newIn force
51-protocols/protocol-amendment-01.pdf
Clinical study report CSR-001newIn force
53-clin-stud-rep/535-rep-effic-safety/csr-001.pdf
Safety narrative (7-day report)appendIn force
53-clin-stud-rep/535-rep-effic-safety/safety-narrative.pdf
→ operates on L-0000-csr · filed seq 0001

The current view is the fold of every operation, not the last folder filed. Step to seq 0002 and watch the seq-0002 replace supersede the original clinical summary and drug-product leaves, the append add a stability supplement alongside the drug product (both stay in force), and the delete tombstone the withdrawn Form 1571 — all recomputed in your browser, no backend.

Why this is more than a toy

The fold and the validator are a faithful, dependency-free port of Consign's real lifecycle engine (packages/ectd-validation/…/lifecycle.ts): materializeCurrentView() replays the operations in sequence order — a replace supersedes its predecessor, an append adds a leaf alongside a predecessor that stays in force, a delete tombstones a prior leaf without touching the archived file — exactly as the product materializes a current view (ADR-CSG-001). The fault injector drives the real validateLifecycleGraph() integrity check: the same seven rules (LIFECYCLE-OP / REF / SELF / ORDER / STATE / CYCLE / DUP-001) that guard a real sequence against dangling predecessors, wrong-order references, and cycles before it is dispatched to a health-authority gateway. The eCTD module spine (m1–m5) and the CTD paths are the real ICH/FDA regional paths. Per ADR-CSG-001 the lifecycle fold is Consign's own deterministic, event-write-bound assembly math, so it lives in-app rather than in Calculate (ADR-PLT-044). Here it runs entirely client-side on a synthetic dossier — no backend, no real data.

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