Submission content is scattered across protocol documents, prior correspondence, and labelling history with no shared source of truth — so every response starts with a manual read-through before anyone can write a word.
Regulatory affairs, medical writing, and labelling teams at pharma and biotech sponsors.
The same registered modules, running on your side of the filing.
document_extraction, compliance_check, and audit_trail are already registered, reusable modules in the Eclypse registry — the same ones that run inside a government health authority's cloud to process incoming submissions. On the sponsor side, they run against your own dossiers before you file: extraction with the source page retained, consistency checks against your own labelling history, and a full audit trail on every draft.
CTD module drafting
Clinical overviews and CTD modules drafted from your governed evidence base, with every claim traced to source.
Labelling consistency
New submissions checked against your existing labelling and prior correspondence, with discrepancies flagged before a reviewer sees them.
Health-authority response drafting
Queries from regulators answered with grounded retrieval — cited language pulled from approved product information, not generated from scratch.
Statistical claim checks
Claims and figures cross-checked against the underlying data before a document leaves the building.
Common questions about regulatory document automation.
Does this replace regulatory affairs judgment?
No. It drafts and cross-checks; a named specialist on your team reviews and signs off before anything is filed.
Where does our submission data live?
Inside your environment — sovereign cloud, on-premise, or air-gapped, the same as every Eclypse deployment. Nothing is sent to a public or foundation model.
Can it draft CTD modules from scratch?
It drafts from your governed evidence base — trial data, prior submissions, and labelling history already in your Validator Framework — not from general knowledge.
Is this the same technology regulators use?
Yes. document_extraction, compliance_check, and audit_trail are the same registered modules Eclypse runs inside government health authority clouds, configured here for the sponsor side of the filing.
Bring us the submission that took longest to draft.
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Our proprietary AI orchestration platform for healthcare: one engine, a registry of reusable task modules and domain agents, and a governed knowledge base — deployed inside your walls and run by your team.