Regulators covered
Which frameworks the life sciences pack maps to today.
Adapter coverage
Upstream services Vortalis adapts for this vertical.
No Vortalis-side adapters ship for this vertical today. The calling system holds the upstream credentials (eCTD publishing tool, regulator portals, document management system, internal-precedent database) and Vortalis governs the action at the agent boundary rather than at the upstream-API boundary.
Action vocabulary
The policy template for this vertical.
Actions allowed
13
Each action gated by policy at the hot path.
Anticipated require_human actions
- ectd.submitted
- csr.signed_off
- cmc.signed_off
- response_to_question.submitted
- protocol_amendment.submitted
Rate-limit posture
200 ectd.module_drafted per 24-hour rolling window; 100 csr.section_drafted per 24-hour rolling window; 100 cmc.section_drafted per 24-hour rolling window; 50 response_to_question.submitted per 24-hour rolling window; 20 ectd.submitted per 24-hour rolling window. Defensible for a single-product regulatory team; multi-product teams raise after agreement with the regulatory-affairs lead.
Template path: policies/sectors/life-sciences/regulatory-submission-template.yaml
Integration brief
The implementation guide your engineers read first.
Available
docs/governance/integration-briefs/life-sciences-regulatory-submission.md
Honest limits
What this sector pack does not do.
Vortalis does not submit dossiers to regulators; AI agents draft, regulatory-affairs leads sign off, the operator submits.
The policy template gates 13 actions including ectd.module_drafted, csr.signed_off, and response_to_question.submitted. The actual submission happens via the operator's eCTD publishing tool and the regulator's submission portal credentials; Vortalis records the regulatory-affairs lead sign-off, the upstream outcome, and the audit-chain entry hash that ties them together. The operator's regulatory-affairs team retains personal responsibility for the regulator-deadline window.
Submission templates and regulator-portal acceptance criteria evolve; the operator's template registry is the source of truth.
eCTD module structures, CMC section expectations under the ICH Q-series, and CSR conventions under ICH E3 each evolve over time. The Vortalis policy template anticipates the action vocabulary; the operator's template registry constrains the agent's drafting to the regulator's current acceptance criteria. Submission rejection on template-version mismatch is captured on the audit chain as an upstream regulator failure.
Personal-responsibility filings (qualified-person CMC sign-off, regulatory-affairs lead submission) are unforgiving; the require_human flow on signed-off actions is mandatory.
Regulatory submission filings carry personal-responsibility weight in most jurisdictions: a named qualified person signs off on the CMC, a named regulatory-affairs lead submits the dossier. The policy template gates ectd.submitted, csr.signed_off, cmc.signed_off, response_to_question.submitted, and protocol_amendment.submitted behind require_human so the personal-responsibility chain is captured on the audit trail alongside the regulator-facing action.
AI-drafted content quality and regulatory-fitness remain the operator's responsibility; the platform records what the agent drafted but does not grade it.
The Vortalis chain captures the agent's drafted content (tokenised under the deny-listed posture), the regulatory-affairs lead's review, and the post-hoc record of the actual submission. The substantive judgement on whether the draft is regulator-fit (consistent with the validated CMC source, accurate to the clinical study data, on-template for the regulator) lives with the operator's regulatory-affairs and medical-writing teams.
The general-purpose honest limits sit at /security/limitations; this list is specific to the life sciences pack.
Bring Vortalis to your life sciences agents.
Read the integration brief if you would rather start with the engineering detail. Talk to us first if you would rather start with a conversation about your threat model.