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Zelthy AI Platform

AI-native workflow automation for patient services, supply chain, compliance, and regulatory operations in pharma.

Solution by Zelthy
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Overview

Zelthy is an AI-native platform designed for life sciences operations, offering a suite of applications that automate complex workflows across patient support programs (PSP), advanced therapies, commercial operations, supply chain traceability, compliance, and regulatory affairs. The platform is used by leading pharmaceutical companies including Roche, Bristol-Myers Squibb, AstraZeneca, MSD, Novo Nordisk, and Servier, with over 300 applications in production across more than 10 countries.

Built on Zango, an open-source Django-based framework developed for regulated industries, Zelthy is positioned as an open, transparent platform with no vendor lock-in. Applications can typically be deployed within 4 to 8 weeks, and the platform maintains 99.99% uptime.

Core Platform Capabilities

  • Open-source Zango framework with built-in role-based access control (RBAC), audit logging, a workflow engine, and a growing package ecosystem
  • Full code transparency — developers can read, modify, and extend every line using standard Python and Django
  • Flexible deployment options: self-hosted, Zelthy cloud, or hybrid, with complete data sovereignty in all models
  • Global Capability Centre (GCC) ready architecture, supporting capability transfer so internal teams can progressively own and extend the platform

Supported Operational Areas

  • Patient Services: digitising patient support programs, compassionate access programs, and care management platforms
  • Advanced Therapies: workflow automation for complex therapy operations
  • Commercial Operations: tools including digital ordering portals for vaccines and other products
  • Traceability and Supply Chain: blockchain-powered product tracking for end-to-end supply chain visibility
  • Compliance: workflow templates and AI agents supporting compliance operations
  • Regulatory Affairs: AI agents covering the regulatory document lifecycle, including classification, drafting, review, and quality checks

Documented Production Outcomes

  • Compassionate access approval times reduced by 65% and costs lowered by 40% for an Australian program
  • Cancer therapy patient adherence improved by 45%, onboarding accelerated by 60%, and patient engagement reaching 85% in an Australian PSP
  • A vaccine ordering portal onboarded over 3,000 clinics, processed more than 12,000 orders in six months, reduced order-to-delivery time by 15%, and increased repeat orders by 25%
  • Blockchain-powered product traceability reduced stockouts by 15% and improved inventory turnover by 25% for a global pharma company
  • A women's health platform cut development time by 60% and lowered costs by 80%
  • AI-powered regulatory document operations reduced outsourced writing costs and improved document quality at scale for a top-10 pharma company

Integration Hub

  • Enterprise systems: SAP (ERP, S/4HANA, ATTP), Oracle (EBS, Cloud ERP, OTM), Salesforce (Health Cloud and MuleSoft), TraceLink (serialisation and DSCSA)
  • Veeva ecosystem: Veeva Vault (PromoMats, MedComms, QualityDocs), Veeva CRM, Veeva RIM, and Medidata Rave
  • Productivity and eSign: Office 365 (Outlook, Excel, Teams), SharePoint, Google Workspace, DocuSign, and Adobe Sign
  • Infrastructure and communications: AWS (S3, Lambda, RDS), Azure (AD, Blob, Functions), Snowflake, Twilio, and NICE CXone
  • Additional connectivity via REST APIs, webhooks, and SFTP for any system with an endpoint

Zelthy supports deployment on cloud, on-premise, or hybrid infrastructure and is built to meet the requirements of regulated industries. The platform's open-source foundation allows internal teams and GCCs to take progressive ownership, reducing long-term dependency on external vendors.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
Hybrid
Industry vertical(s)
PharmaBiotech
Development stage(s)
ClinicalManufacturingPost-Market & RWE
Target user(s)
QA / Regulatory AffairsCommercial / Market AccessIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP
Tag(s)
Uses AIOpen source