Regulatory bundle · for VP Regulatory Affairs
One governed evidence chain from analysis to label
Compend, Consign, Consulate, and Cachet share the same governed OMOP record, so the dossier you publish, the registration it earns, and the label it governs stay one linked story instead of four reconciled silos.
The problem today
Regulatory work fragments across an eTMF, a publishing tool, a RIM tracker, and a labeling system that never agree, forcing reg ops to re-key and reconcile evidence by hand at every handoff.
Faster
No re-keying at the handoff
Compend packages, Calculate outputs, and Consulate registration identifiers flow straight into Consign sequences and Cachet labels instead of being reassembled by hand.
Better
Evidence-linked, inspection-ready
Every sequence, registration, and label change traces back to the governed evidence and conduct events that produced it, so inspection readiness is grounded in actual study activity, not a generic checklist.
Cheaper
One stack, one validation story
Four regulatory surfaces on one governed substrate replace per-vendor licenses, integration projects, and a separate validation effort for each tool.
How this bundle composes
Carry governed evidence through sequence publishing, registration, and label lifecycle.
Assemble, validate, seal, and dispatch eCTD sequences from governed upstream evidence, with the full sequence lifecycle managed as first-class state rather than folder conventions.
Author SPL / Prescribing Information and manage the label-version lifecycle against a structured product record, with every market's label and approval status kept in lockstep.
Track global registration status, variations, renewals, commitments, and health-authority interactions as lifecycle events on a governed record linked to the submissions and labels that produced them.
Hold trial-conduct evidence in continuous, inspection-ready custody against the DIA TMF Reference Model, with documents cross-linked to the study events they evidence.
RWD-to-submission evidence chain
Trace one adverse event from the bedside to the submission gateway — Capture flags the out-of-range AE lab, Canary works it up into an E2B(R3)-shaped safety case with a validated disproportionality signal, Compend files the safety narrative into a DIA-TMF zone with an inspection-readiness score, and Consign folds it into the assembled eCTD sequence as a Module 5 leaf — each stage consuming the last.
Capture the adverse event at the bedside
A coordinator enters S-2001's labs at the AE visit for the ravucizumab study (VELT-042). Capture's real edit-check core flags the out-of-range hemoglobin — the acute-blood-loss lab behind the reaction.
Hemoglobin value 7.4 g/dL is outside the reference range (12–17.5). Please verify the source.
Capture's real field-save auto-query core, run on S-2001's AE-visit values — the low hemoglobin is the acute-blood-loss lab that evidences the GI haemorrhage reaction. Each query carries a 21 CFR Part 11 attribution (source AUTO, opened by the system user).
The captured suspect-product + reaction crosses to Canary as a pharmacovigilance case (a small adapter re-keys it onto Canary's surveillance subject — the engines were vendored separately, so the AE's identity is carried across, nothing is fabricated).
This is the full cross-app journey — open it alongside every CuRE journey.
Why it holds up
- One governed evidence chain spans analysis, submission, registration, and label — registration status, the submission sequence that produced it, and the label it governs stay one linked record.
- Finished Cachet labels and Compend packages publish through Consign sequences, so there is one publishing pipeline with no export-and-rekey at the boundary.
- Product master data comes from the platform's IDMP substrate in Conduct — one product definition shared across registrations, labels, and submissions.
- Every artifact carries a 21 CFR Part 11 / Annex 11 hash-chained audit trail under RLS-isolated tenancy, so regulatory records share one coherent compliance posture.
The apps in this bundle
Assemble, validate, seal, and dispatch eCTD sequences from governed upstream evidence, with the full sequence lifecycle managed as first-class state rather than folder conventions.
- 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 for a publishing operator to confirm or correct with an e-signature, renders source content to submission-grade PDF/A, and blocks a sequence on broken hyperlinks or cross-references — one immutable reviewed snapshot drives both QC and assembly, so preflight and assembly never diverge.
Author SPL / Prescribing Information and manage the label-version lifecycle against a structured product record, with every market's label and approval status kept in lockstep.
- AI-assisted label authoring grounded in the structured product record — drafts cite the registration and submission facts they came from.
- A Company Core Data Sheet drives country/local label derivation, and label safety content reconciles against the platform safety source-of-truth (Canary/RWD) — the connected-safety edge standalone labeling vendors lack.
Track global registration status, variations, renewals, commitments, and health-authority interactions as lifecycle events on a governed record linked to the submissions and labels that produced them.
- Registration status, the submission sequence that produced it, and the label it governs stay one linked record — not three systems reconciled by spreadsheet.
- Trial disclosure (FDAAA 801 / EU CTIS) and a section-level submission content plan — the RIM capabilities a Veeva-comparing buyer asks for first.
Hold trial-conduct evidence in continuous, inspection-ready custody against the DIA TMF Reference Model, with documents cross-linked to the study events they evidence.
- Document-to-data cross-links tie TMF artifacts to study events, so inspection readiness is grounded in actual conduct rather than a generic checklist.
- An Expected Document List gives inspection-readiness a denominator, and AI completeness detection grounds gap-finding on the study's actual config (visits, sites, amendments).
See the Regulatory bundle in action
Every research ecosystem is unique. Let's discuss how CuRE can be configured for your team.