One platform, three workflows, one audit trail.
Praxara gives regulatory, PV, and quality teams a shared system of record. Upload documents, run AI skills against them, review with e-signature, export to submission-ready formats — all on the same tamper-evident chain.
The three modules
Each module ships with a set of AI skills, workflow templates, reviewer queues, and exports tailored to the regulatory artefact you're delivering.
eCTD Module 1-5 structure, gap analysis, cross-reference checking, readiness traffic lights for IND, NDA, MAA, variations, post-approval commitments.
- 60+ document types
- Gap analysis skill
- eCTD traffic-light readiness
ICSR intake (manual + E2B inbound), MedDRA coding suggestions, ICH E2D safety narratives, E2B(R3) export, PSUR/PBRER draft builder, signal tracking.
- E2B(R3) inbound + outbound
- MedDRA AI coding
- PSUR draft generator
PSMF against GVP Module II, SOP structural review, 21 CFR Part 11 readiness, gap analysis against published rule sets. Findings with evidence + recommendation.
- GVP Module II rules
- SOP structure rules
- Readiness scorecard
What runs underneath every workflow
The features that make the modules actually safe to use in a regulated context.
Every action hashes the previous entry. Chain verification endpoint for inspectors. Exportable to CSV for regulator review.
Password + reason code (controlled vocabulary) + timestamp + bound to identity. Prior-agreement captured at activation.
Items route to the right person with SLA. My queue view per reviewer. Overdue alerts. 4-eyes gates available.
Documents nest into Module 1/2/3/4/5. Readiness dashboard shows gaps before inspectors do.
1536-dim embeddings. Ask in plain English, get relevant passages from any doc in your tenant.
SSE push for processing, review, compliance events. In-app bell + optional email digests.
Every row filtered by tenant at app + DB level. Postgres RLS policies enabled in production.
Gemini 3.1 Pro primary. Claude + GPT-4o fallbacks. Per-task DB-configurable routing with cost + latency audit.
EU AI Act Annex IV technical file maintained in-platform. Risk severity x likelihood x mitigation tracking.
Plays nicely with what you already run
Praxara is designed to complement, not replace, your RIM + EDC + safety database stack.
Primary OCR for scanned PDFs, tables, sections.
text-embedding-3-small for pgvector semantic search.
Swap providers per task via DB-backed routing.
Multi-currency billing: GBP / EUR / USD.
Transactional email + digests.
Error tracking + request tracing.
Roadmap Q3 2026.
Roadmap Q4 2026.
See it against your own documents.
20-minute demo. Bring a redacted CSR, PSMF, or ICSR. We'll run it live end-to-end.