What we do
Praxara is a multi-tenant SaaS platform that pharmaceutical regulatory and pharmacovigilance teams use to make AI-assisted workflows legally defensible. We don't replace Veeva or Argus -- we govern the AI that touches your existing system-of-record content with audit chains, e-signed approvals, model cards and a Compliance Pack that QA hands straight to inspectors.
Who it's for
- Regulatory Affairs -- CSR / EPAR / submission document intelligence with reviewer-canvas + e-sign
- Pharmacovigilance -- ICSR processing, MedDRA suggestion, narrative drafting, signal management, EURD calendar
- Quality / Compliance -- AI model cards, GDPR Article 30 ROPA, 21 CFR Part 11 evidence, audit chain verification
Frameworks supported
EU AI Act (Annex III, Articles 9 / 11 / 13 / 14) · EU GxP Annex 22 (draft) · 21 CFR Part 11 e-records and e-signatures · GDPR Articles 5 / 6 / 13 / 14 / 17 / 28 / 30 / 35 · ICH E2B(R3) · GVP Modules II / V / VI / VII / IX.
Hosting + data residency
Microsoft Azure UK South + West Europe. Customer Data does not leave the EU/UK at rest. Limited transfers occur for AI inference (Anthropic / Google AI / OpenAI) and transactional email (SendGrid). All sub-processors are listed at /legal/subprocessors with their function, location, lawful-basis instrument (UK IDTA / EU SCCs Module 2 or 3) and data categories.
Pricing tiers
- AI Readiness Snapshot -- GBP 2,500 one-time, 3-business-day delivery, no platform sign-up
- Compliance Pack Starter -- GBP 5,000 one-time, 5-business-day delivery, 8 artefacts
- Compliance Pack Full -- GBP 30,000 / year, concierge onboarding, quarterly refresh, auditor share-links
- Platform Pilot -- from GBP 3,000 / month, 50 seats, one product workflow
- Enterprise / Design Partner -- custom, from GBP 100K / year
Procurement
- Sales: [email protected]
- Security disclosures: [email protected]
- Privacy / DPO: [email protected]
- Trust portal: praxara.io/trust (status, sub-processors, completed questionnaires)
- Legal pack: praxara.io/legal (Terms / DPA / E-Sig / AUP / Privacy / Cookies / Subprocessors)