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.
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.
- 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.
Nexoraa
Governed connectors
13
systems named here
- Argus
- ArisGlobal
- Veeva (Vault
- CRM
- RIM)
- Oracle Argus
- Master Control
- Trackwise
- Documentum
- eTMF systems
- EDC platforms (Medidata
- Veeva CDB)
- 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.
- 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.
Bring an existing workflow under NDA. We will demonstrate the platform on it.