Agentic execution for pharmacovigilance, regulatory submissions, and clinical operations.
Nexoraa runs inside GxP-aligned environments — case intake and triage, submission evidence, and clinical operations — with the validation, audit, and 21 CFR Part 11 controls these processes require.
The operational landscape we serve.
Pharma operations are evidence-heavy, audit-heavy, and slow to change, with strict validation and retention requirements at every step. The opportunity for governed AI is enormous, and so is the bar to deploy it. Nexoraa clears it: validated workflows, immutable audit, source-grounded outputs, and human sign-off as a first-class capability.
FDA · EMA · CDSCO · MHRA · PMDA · ANVISA · TGA · GxP frameworks — with 21 CFR Part 11 and Annex 11 considerations baked in.
Workflows Nexoraa executes in this industry.
Pharmacovigilance Case Intake
Multi-channel case intake (literature, spontaneous reports, partners), extraction into the safety database schema, and triage routing.
Literature Monitoring
Continuous monitoring of literature sources against safety signals; structured summarisation with cited articles.
Regulatory Submissions Support
Evidence assembly across CMC, clinical, and non-clinical sources; pre-validation of submissions for completeness.
Clinical Operations Support
Site monitoring evidence, deviation classification, query response drafting — with audit retention.
Quality & Compliance Operations
Deviation intake, classification, CAPA support, and audit evidence assembly per GxP requirements.
Medical Information
Inquiry triage, evidence retrieval from approved sources, response drafting under medical review.
Systems we integrate with in this industry.
Argus, ArisGlobal, Veeva (Vault, CRM, RIM), Oracle Argus, Master Control, Trackwise, Documentum, eTMF systems, EDC platforms (Medidata, Veeva CDB), and corporate ERP/QMS/document management.
Governance posture for this industry.
GxP and 21 CFR Part 11 require validation, audit, and electronic signature. Nexoraa supports validated deployment, immutable audit trails, electronic signature workflows, role-based segregation of duties, and Haluvance enforcement so that no medical or regulatory action runs without explicit, signed permission. Workspace isolation prevents cross-program data access.
Deployment posture for this industry.
Validated private cloud or on-premise. Self-hosted LLM models are typical; retrieval is restricted to approved content sources; medical and regulatory outputs go through dual-control review.
Why Nexoraa for this industry.
GxP-aligned
Validated deployment, audit trails, electronic signature workflows.
Source-grounded medical outputs
Haluvance blocks any medical or regulatory output that lacks cited evidence from approved sources.
Workspace isolation per program
Cross-program data access is prevented at platform level.
Sign-off-first
Human review and electronic signature are first-class capabilities, not bolt-ons.
See Nexoraa applied to a workflow in your environment.
Bring an existing workflow under NDA. We will demonstrate the platform on it.