# Zelthy > Zelthy is the agentic AI platform for life sciences — a new operating layer with 100+ AI agents that reason, act, and adapt to automate the most complex pharma workflows across commercial, medical, and compliance. Built on the open-source Zango framework, Zelthy serves 6 of the top 10 global pharma companies across 12+ countries with 300+ applications in production. ## Core - [Agentic AI Platform for Life Sciences | Zelthy](https://www.zelthy.com/): The Zelthy agentic platform — 100+ AI agents that reason, act, and adapt to automate life sciences workflows across commercial, medical, and compliance. Zelthy is the agentic AI platform for life sciences. A new operating layer for pharmaceutical companies — 100+ AI agents that reason, act, and adapt to automate the most complex workflows across commercial, medical, and compliance. **Hero:** The Agentic Platform for Life Sciences. 300+ Production Deployments. 10+ Countries. 10x Faster deployment. 99.99% Platform uptime. Trusted by Roche, Bristol-Myers Squibb, MSD, AstraZeneca, DKSH, Novo Nordisk, Servier. **Solutions (Agent Blueprints):** - Patient Services: A single platform covering enrollment, call centre ops, adherence monitoring, and benefits verification. AI agents detect adverse events in real-time during calls and predict patient drop-off before it happens. - Advanced Therapies: Orchestrates the full vein-to-vein journey — from apheresis scheduling through manufacturing slots, cold chain monitoring, infusion coordination, and 15+ year post-treatment follow-up. AI coordinates multi-stakeholder handoffs and flags chain-of-custody anomalies. - Commercial Operations: Connects the full commercial engine — distributor and stockist management, clinic and hospital ordering, field force operations, trade scheme automation, and AI-powered demand intelligence from primary through tertiary data. - Traceability & Supply Chain: Turns compliance serialisation data into commercial intelligence — real-time authentication, automated regulatory reporting, and AI that predicts stockouts from serialisation events and detects diversion patterns. - Compliance: Four AI-native layers — Know (regulatory change mapped to impacted SOPs in minutes), Watch (8 AI agents monitoring every business process continuously), Guide (AI copilot answering policy questions with specific citations), Run (75+ purpose-built compliance systems deployed in 4–8 weeks). - Regulatory: Accelerates regulatory timelines — AI agents draft CSR sections from clinical data, assemble eCTD packages, monitor health authority changes, and track submissions across jurisdictions. **Platform stats:** 300+ applications in production · 10+ countries live · 4–8 weeks average deployment · 99.99% uptime. - [Open-Source Life Sciences App Framework | Zelthy](https://www.zelthy.com/platform): Zango, a Django-based open-source framework for regulated industries providing enterprise-grade features, full code ownership, and 4–8 week deployment timelines. Zelthy's platform is built on Zango — an open-source Django-based framework designed for regulated industries. Platform engineered to deliver apps where AI Agents are first-class citizens — visible, compliant, and governed. Not bolted on. Architected in. **Three-layer architecture:** Layer 1 — Application Layer (Top): Application Templates with Native Agents. Pre-built templates covering: Patient Services, HCP Engagement, Adverse Events, Field Monitoring, Training & Compliance. Each template ships with AI agents built in. Layer 2 — Middleware: Packages & Agent Blueprints. - Application Packages: Workflow Engine, CRUD, Communication, RBAC, Audit Logging, Login & Auth. - Agent Blueprints: Enrolment Agent, Ghost Patient Detection, Adverse Event Monitor, Field Visit Validator, Document Processor, Compliance Checker. Layer 3 — Foundation (Open Core): Zango Agentic App Framework. - Platform Primitives: Multi-tenancy, User Mgmt & Auth, RBAC, Policy Engine, Audit Trails, Observability. - Agent Harness: Runtime for governed, observable AI agents — visibility, compliance, and control built in from the start. **Key outcomes:** - Go-live in weeks: Pre-built templates cut implementation from months to weeks - Full customization: Modify any workflow, screen, or business rule — no limits - AI-native operations: Native agents automate compliance, monitoring & reporting - No vendor lock-in: Open-source core — your team owns and extends everything - Compliance built-in: GxP, HIPAA, SOC 2 and audit trails from day one **Platform advantages:** - Unlimited Template Customization: Every application template is fully editable. Modify workflows, forms, dashboards, and business logic to match your exact programme requirements. (No-limits customization) - Custom Agents: Build and deploy purpose-built AI agents tailored to your life sciences workflows — from patient enrollment to adverse event monitoring. (AI-native extensibility) - Deployment Ready: Production-grade templates ship with built-in compliance, audit trails, and role-based access. Deploy to cloud, on-premise, or hybrid infrastructure. (Cloud · On-Premise · Hybrid) - Open Core: Built on Zango — an open-source Django framework. Your developers read, modify, and extend every line. No proprietary lock-in. (pip install zango) **Comparison — Zango vs alternatives:** | Attribute | Proprietary Platforms | Web Frameworks | Low-Code | Zango | |---|---|---|---|---| | Dev Speed | Medium | Slow | Fast | Fast | | App Complexity | Complex | Complex | Simple | Complex | | Platform Type | Proprietary | Open | Proprietary | Open | | Operational Cost | High | Low | High | Low | | Compliance Built-in | Yes | No | No | Yes | | Code Ownership | No | Yes | No | Yes | **Key facts:** Python stack · Django framework · 100% open source · 4–8 week average deployment. Install: `pip install zango`. GitHub: github.com/Healthlane-Technologies/Zango. - [About Zelthy | AI-Native Platform for Life Sciences](https://www.zelthy.com/about): Company background, founding team, mission, and approach to building transparent, open-standard solutions for enterprise pharma. **Mission:** Life sciences deserves a modern platform. Zelthy is the application platform built for life sciences — giving pharmaceutical companies the enterprise guardrails they need with the open standards, speed, and modern technology they've been waiting for. **Why we exist:** Life sciences companies run on legacy enterprise systems — ERPs, point solutions, and platforms built two decades ago. These systems are expensive to maintain, difficult to customise, and impossible to extend without deep vendor dependency. Every new market, every new therapy, every new regulation means months of integration work. Zelthy is a platform-as-a-service for life sciences — where the same infrastructure that keeps you compliant also makes you fast. **Key stats:** 50+ employees · 10+ countries live · 300+ applications in production · 1M+ patients impacted. **Values / Principles:** - Open by default: Open-source core, open standards, full code transparency. Built on Django and Python because the talent pool is global and the ecosystem is battle-tested. - Domain depth over feature breadth: Every template, every AI agent, every workflow is shaped by how life sciences actually operates — the regulatory constraints, the patient journeys, the supply chain complexity. - Ownership transfers, not vendor lock-in: The endgame of every Zelthy engagement is your team running the platform independently. Built on open standards so capability transfers to your GCC or internal team. - Weeks, not quarters: Pre-built templates covering 70–80% of the solution, configured for specific context, mean production in weeks. **Operating principles:** - Deep domain, not domain tourism: Every engineer, designer, and operator builds real intuition for how pharma actually works. - Ownership over process: Problems have owners, and owners ship solutions. - Speed is a value, not a metric: Production in weeks — not because corners get cut, but because the hard problems have been solved once. - Rigour over ceremony: Rigorous where it matters — zero tolerance for theatre. - Enterprise trust, startup tempo: Clients are top-10 pharma; internal culture is closer to a 20-person startup. - Build for the builder: Half the platform is open source because the best enterprise software is software other engineers want to use. **Timeline:** - 2017: Founded in Bengaluru by Anshuman and Kaustubh as Healthlane Technologies. - 2018: First production deployment — track-and-trace platform with a top-10 pharma company in India. - 2022: Asia's largest pharma PSP and Track & Trace provider. Live across Southeast Asia, ANZ, and Middle East. - 2023: US expansion — Dover, Delaware office opened for strategy, partnerships, and enterprise client engagements. - 2024: Zango open-sourced — core framework released to the broader regulated-industry developer community. - 2025: AI agents ship across all verticals. Platform live in 10+ countries with 300+ applications in production. **Locations:** - Bengaluru, India: Engineering & Operations HQ — platform engineering, product development, domain consulting, and client delivery. - Dover, US: Strategy & Market Development — US market development, enterprise partnerships, and strategic initiatives. **FAQ:** - What is Zelthy? An AI-native application platform for life sciences with pre-built templates, AI agents, and enterprise infrastructure to deploy applications in weeks instead of months. Built on open-source standards (Django, Python). - Who uses Zelthy? Global pharma and biotech companies including several top-10 pharma organisations. Live in 10+ countries, impacting 1M+ patients. - Is Zelthy open source? Yes — the core framework (Zango) is open source on Django/Python with full code transparency. - What industries does Zelthy serve? Life sciences exclusively — six verticals: patient services, advanced therapies, commercial operations, traceability, compliance and quality, and regulatory affairs. - How is Zelthy different from legacy pharma platforms? Open standards (Django, Python), 4–8 week deployments using pre-built templates, AI agents for workflow automation, progressive ownership transfer to client teams. Multi-tenancy reduces infrastructure costs by 50–70%. - Is Zelthy HIPAA and GDPR compliant? Yes. RBAC, full audit trails, data encryption, consent management, adverse event capture. GxP-compliant. - How to get started? 1–2 week operational mapping phase, then 4–8 week deployment on pre-built templates, then ongoing optimisation and ownership transfer. - [Zelthy Customers | Trusted by 6 of the Top 10 Pharma](https://www.zelthy.com/customers): Production outcomes and customer success stories from top global pharma companies including Roche, BMS, AstraZeneca, MSD, Novo Nordisk, and DKSH. 6 of the top 10 global pharma companies · 10+ countries with live deployments · 300+ applications in production · 1M+ patients on Zelthy-powered programs. Clients include: Roche, Bristol-Myers Squibb, MSD, AstraZeneca, DKSH, Novo Nordisk, Servier, Pfizer. **Production outcomes (all from live deployments):** Patient Services: - 45% adherence improvement — Oncology PSP replaced paper-based enrolment and manual call scheduling with AI-driven workflows. (Global top-10 pharma, Australia, 6-week deployment) - 60% faster patient enrolment — Digital enrolment with e-KYC cut onboarding from 10 days to under 4. (Global top-10 pharma, Australia/multi-site, 6-week deployment) - 65% faster compassionate access approvals — 12-step manual approval process averaging 22 days digitised end-to-end. (Leading global pharma, Australia/national, 5-week deployment) Advanced Therapies: - Zero missed handoffs in production — Cell and gene therapy orchestration platform connecting treatment centres, manufacturers, and couriers on a single workflow. (Global top-10 pharma, Southeast Asia, 8-week deployment) - 100% chain-of-custody visibility — End-to-end tracking from cell collection through manufacturing to infusion with temperature monitoring. (Global top-10 pharma, Southeast Asia) Commercial Operations: - 3,000+ clinics onboarded — Vaccine ordering moved from phone calls to a self-service digital portal. (Leading global pharma, India/national, 6-week deployment) - 25% repeat order increase — Reducing friction from 12-day manual processes to same-day digital workflows. (Leading global pharma, India) Traceability: - 15% stockout reduction — AI-driven demand prediction from traceability data. (Top-10 pharma, India & Southeast Asia/12+ countries) - 100% end-to-end chain visibility — Serialisation, authentication, last-mile tracking, and supply chain analytics on one platform. (Top-10 pharma) Compliance: - 70% less manual compliance documentation — Automated audit trail management; inspection preparation dropped from weeks to hours. (Global pharma, multi-market) - 100% audit trail coverage — Every user action automatically logged with tamper-evident records. (Global pharma) Regulatory: - 40% faster regulatory submissions — Unified across 8 jurisdictions; AI agents monitor requirement changes and flag dossier gaps. (Top-10 pharma, Asia-Pacific) - Zero missed submission deadlines — Single pipeline view across 8 health authorities. (Top-10 pharma, post-deployment) **Live across 10+ countries:** India, Australia, Singapore, Malaysia, Thailand, Philippines, Indonesia, Vietnam, UAE, Saudi Arabia, New Zealand, South Korea. US and EU expansion underway. - [Contact Zelthy | Request a Demo or Architecture Review](https://www.zelthy.com/contact): Contact the Zelthy team to request demos, architecture reviews, or discuss modernising pharma operations. ## Solutions - [AI Patient Support Program Platform | Zelthy](https://www.zelthy.com/solutions/patient-services): Launch patient support programs in weeks with AI agents across the entire patient journey — enrolment, adherence monitoring, pharmacovigilance, and outcomes reporting. **Headline:** Patient programs that actually drive outcomes. **Point of view:** The industry spends billions on patient support programs that most patients never touch ($5B in PSP spending, 3% patient enrolment). Fragmented vendors, disconnected systems, and reactive workflows mean coordinators spend more time on data entry than patient interaction. Zelthy ships AI agents that automate enrolment validation, call scheduling, and adherence prediction — so teams focus on work that moves patient outcomes. **Patient journey covered:** 1. Identification — Digital referral portals for HCPs; automated eligibility screening; AI surfaces patients likely to benefit from clinical and claims signals. 2. Enrolment — Digital self-service enrolment with e-KYC, automated document verification, insurance validation, consent management. AI reads prescriptions and IDs to pre-fill forms. Average enrolment reduced from 7–10 days. 3. Therapy Support — Unified coordinator workspace; AI-driven call scheduling; automated refill reminders; nursing visit routing; every interaction logged to a single patient record. 4. Adherence — AI agents monitor refill patterns, appointment attendance, and engagement signals in real time. Predictive risk scoring identifies drop-off 2–3 weeks ahead. Automated interventions before disengagement becomes permanent. 5. Outcomes — Real-time outcomes dashboards; automated reporting for payers and internal stakeholders; AI-generated insights on program effectiveness. **Templates:** Enrolment & Onboarding, Call Centre (CareOps), Co-pay & Benefits Verification, Adherence & Monitoring, Digital PSP Portal, Compassionate Access. **AI agents included:** Enrolment Agent, Eligibility Checker, Calling Agent, Scheduling Agent, Adherence Monitor, Risk Predictor, Intervention Agent, Benefits Verification Agent. **Deployment journey:** Map (1–2 weeks) → Deploy (4–8 weeks) → Optimise (ongoing) → Own (progressive). **Production metrics:** 45% adherence improvement · 60% faster enrolment · 65% reduction in approval time · 30% lower operational costs. **Therapy types:** Oncology (Opdivo, Keytruda), Immunology (Dupixent), Haematology (Darzalex Faspro), Rare Disease, Compassionate Access. - [Cell & Gene Therapy Orchestration Platform | Zelthy](https://www.zelthy.com/solutions/advanced-therapies): AI-powered orchestration for the cell and gene therapy lifecycle, from patient identification through vein-to-vein scheduling, chain of identity tracking, and post-treatment monitoring. **Headline:** Every handoff orchestrated. Every therapy delivered. **Point of view:** Cell and gene therapies are the most logistically complex treatments ever created. A single missed handoff can cost a patient their therapy. Dozens of stakeholders, cold chain handoffs, REMS compliance, and decades of follow-up — most of it coordinated by email and spreadsheets. Zelthy connects every stakeholder on a single orchestration platform with AI agents that manage scheduling conflicts, flag chain-of-custody gaps, and ensure compliance documentation is complete. **Therapy lifecycle covered:** 1. Referral — Digital referral portal; real-time slot visibility based on manufacturing capacity; AI-powered matching by geography, therapy type, and urgency. 2. Cell Collection (Apheresis) — Multi-stakeholder scheduling engine aligning patient readiness, centre capacity, courier logistics, and manufacturing capacity simultaneously. Automated rescheduling when any dependency shifts. 3. Manufacturing — Real-time manufacturing status; automated chain-of-identity verification at every handoff; continuous temperature monitoring; full audit trail from collection to release. 4. Logistics — End-to-end shipment tracking with live temperature monitoring. AI-driven logistics planning accounting for transit times, customs, weather. Proactive alerts when delivery timelines are at risk. 5. Treatment & Follow-up — Automated follow-up scheduling tied to therapy-specific protocols. AI-driven patient re-engagement for missed follow-ups. REMS compliance monitoring. 15+ year long-term safety data collection. **Templates:** Patient ID & Referral, Apheresis Scheduling, Chain of Custody, REMS & Compliance, Infusion Coordination, Post-treatment Monitoring. **Production metrics:** 60% faster patient onboarding · 100% chain-of-custody visibility · Zero missed handoffs · 15-year follow-up management. - [Pharma Commercial Operations Platform | Zelthy](https://www.zelthy.com/solutions/commercial-operations): Unified digital system for field force management, HCP engagement, distributor coordination, and commercial analytics across pharma markets. **Headline:** The entire commercial engine. One platform. **Point of view:** Pharma commercial operations is not one workflow — it's an entire machine. Primary sales to C&F agents, secondary redistribution to stockists, institutional tenders for hospitals, retail ordering from clinics and pharmacies, field force coordination across thousands of territories, trade schemes, and expiry returns. Most companies run each piece on a different system — or no system at all. Zelthy connects the full commercial chain on one platform. **Commercial engine covered:** 1. Channel Setup — Unified channel management for distributors, super stockists, stockists, hospitals, clinics, pharmacies. Self-service onboarding portals. Automated credential verification. Tiered pricing and credit terms per channel type. 2. Ordering & Fulfilment — Digital ordering across all channels: distributor portals, stockist apps, clinic self-service, institutional ordering tied to tender pricing. Real-time inventory visibility at every tier. AI-powered reorder suggestions. 3. Field Operations — Territory management with AI-optimised visit planning based on prescription potential. Digital detailing and sample management. Doctor engagement scoring linked to actual secondary sales data. 4. Trade & Incentives — Digital scheme configuration; automated claim submission and validation against actual sales data; reconciliation in days not weeks; AI-powered scheme ROI analysis by channel, geography, and product. 5. Commercial Intelligence — Unified primary, secondary, and tertiary data. AI-powered demand forecasting from real consumption patterns. Distributor performance scoring. Predictive stockout alerts. Diversion detection. **Templates:** Distributor & Stockist Management, Clinic & Pharmacy Ordering, Institutional & Hospital Business, Field Force Operations, Trade Schemes & Claims, Returns & Reconciliation. **Production metrics:** 3,000+ channel partners onboarded · 12,000+ monthly orders processed · 40% faster scheme reconciliation · 5 markets on one platform. - [Pharma Serialisation Solution Provider | Zelthy](https://www.zelthy.com/solutions/traceability): India's leading pharma serialisation solution provider. DCTS, CDSCO & MoHFW Drug Barcode compliant. End-to-end serialisation, anti-counterfeiting, and last-mile tracking — also covering DSCSA, EU FMD, and 12+ global markets. **Headline:** See every product. From factory to patient. **Point of view:** 52% of pharma plants implementing DSCSA standards skipped aggregation because it wasn't mandated. Most companies treat traceability as a compliance cost. It's a competitive weapon. Zelthy layers AI on top of traceability infrastructure — the same data that proves regulatory compliance also predicts stockouts, optimises inventory, and identifies diversion. **India DCTS & Serialisation:** Zelthy is deployed across Indian pharma manufacturers and C&F agents for end-to-end DCTS (Drug Coding and Tracking System) compliance under the MoHFW Drug Barcode mandate. The platform handles serial number generation, DataMatrix barcode encoding at unit and case level, SSCC aggregation, and automated event reporting to the MoHFW government portal. It integrates with ERP and packaging lines and provides C&F agent portals for downstream supply chain event capture. Indian manufacturers go live in 4–8 weeks. **India regulatory context:** - DCTS (Drug Coding and Tracking System): India's national serialisation and track-and-trace system under MoHFW. Requires manufacturers to generate unique serial numbers, encode DataMatrix barcodes, and report supply chain events to the central government portal. - CDSCO (Central Drugs Standard Control Organisation): National regulatory authority enforcing the Drug Barcode mandate under Schedule M. Inspects manufacturing facilities for serialisation compliance and coordinates with state drug controllers. - MoHFW Drug Barcode: Mandatory DataMatrix barcode on all primary and secondary packs encoding GTIN, batch number, expiry date, and serial number. Phased rollout by product category. **Supply chain covered:** 1. Encoding — Complete serialisation from unit to pallet with full aggregation. GS1-compliant GTINs and SSCCs supporting DSCSA, EU FMD, India DCTS, and emerging-market regulations. Manufacturing data linked to every serial number. 2. Distribution — Unified tracking across all tiers. Secondary and tertiary sales capture through distributor and C&F agent portals and mobile apps. AI-powered anomaly detection for potential diversion. 3. Authentication — QR-based verification for distributors, pharmacists, and patients. Real-time counterfeit detection. Authentication events feed back into supply chain intelligence. 4. Last Mile — Last-mile delivery tracking with digital proof of delivery. Temperature monitoring for cold-chain products. Pharmacy-level inventory visibility. 5. Intelligence — Micro-market demand signals from tertiary sales. Distributor performance scoring. Predictive stockout alerts from serialisation events. Diversion detection from anomalous distribution patterns. **Templates:** Serialisation & Encoding, India DCTS Compliance, Authentication & Verification, Inventory Intelligence, Last-mile Tracking, Regulatory Reporting (DSCSA, EU FMD, India DCTS), Supply Chain Analytics. **India's largest pharma track-and-trace provider.** Live in 12+ countries. **Production metrics:** 100% chain visibility · 15% stockout reduction · 25% inventory turnover improvement · 12+ countries live · 4–8 weeks India DCTS go-live. - [Life Sciences Compliance & Quality Platform | Zelthy](https://www.zelthy.com/solutions/compliance): Automate GxP compliance workflows including audit management, CAPA tracking, change control, deviation management, and 21 CFR Part 11-compliant documentation. **Headline:** Inspection-ready. Every day, not just audit day. **Point of view:** GxP compliance in pharma is an exercise in documentation management. Teams spend 60–70% of their time maintaining audit trails, updating SOPs, tracking training records, and preparing for inspections. Zelthy automates the documentation layer entirely. Every action generates an audit trail. AI agents detect compliance gaps in real time, flag adverse event patterns, and keep inspection packages current. **Four AI-native compliance layers:** 1. Know — AI monitors regulatory sources continuously; maps every change to your policies, SOPs, and active programs; impact analysis and owner assignment in minutes not weeks. 2. Watch — 8 specialised AI agents running continuously across every business process (HCP engagement, speaker programs, aggregate spend, PSP conduct, AE capture rates). 100% transaction coverage, not sampling. 3. Build — AI drafts policies and SOPs from regulatory source material. Automated review cycles, controlled distribution, training assignment when documents change. 4. Guide — AI copilot grounded in your actual policies; answers policy questions in 30 seconds with specific citations; 80% of queries resolved without escalation. 5. Run — 75+ pre-built compliance system templates (audit management, CAPA, COI disclosures, market risk scoring) deployed in 4–8 weeks. DOJ-aligned effectiveness measurement built in. 6. Report — Sunshine Act, EFPIA, and Open Payments aggregation. Real-time OIG, OFAC, and global sanctions screening. Automated disclosure submissions. **Templates:** Pharmacovigilance, Audit Trail Management, SOP Management, GxP Documentation, Training & Qualification, CAPA Management. **Production metrics:** 100% audit coverage · 70% less manual documentation · Real-time signal detection · 4–8 weeks to deployment. - [AI-Native GRC Platform for Life Sciences | Zelthy](https://www.zelthy.com/solutions/compliance/grc): Governance, risk, and compliance unified on one AI-native platform for pharma — policy governance, enterprise risk scoring, continuous monitoring, and AI agents. Deployed in weeks. **Headline:** The AI-native GRC platform for life sciences. **Point of view:** Governance, risk, and compliance have lived in three silos for too long. Most pharma companies run policy governance on one tool, risk on another, and compliance monitoring on a third — with no shared data model and no unified audit trail. Zelthy unifies all three on one intelligence layer: policies that govern themselves, risk that scores in real time, and compliance monitored continuously by AI agents. **Three unified pillars:** 1. Policy & Programme Governance — Policy lifecycle management, SOP governance, committee oversight, and accountability mapping. AI drafts policies from regulatory source material, manages review cycles, and assigns training when documents change. 2. Enterprise & Third-Party Risk — A living risk register that scores enterprise, third-party, and market risk continuously. Country CPI, enforcement history, and vendor conduct feed an always-current risk picture. Audit resources go where they matter. 3. Continuous Compliance Monitoring — 8 specialised AI agents running across every business process (HCP engagement, speaker programs, aggregate spend, PSP conduct, AE capture rates). 100% transaction coverage, not sampling. **Key facts:** 12+ compliance domains · One data model · One audit trail · Deployed in 4–8 weeks. - [Regulatory Affairs Platform for Pharma | Zelthy](https://www.zelthy.com/solutions/regulatory): Streamline regulatory submissions, registration tracking, dossier management, and regulatory intelligence across the FDA, EMA, CDSCO, PMDA, and other health authorities. **Headline:** Submissions faster. Across every jurisdiction. **Point of view:** Every new market means tracking different requirements, assembling different dossier formats, managing different health authority timelines, and coordinating labelling changes. Regulatory teams are managing more jurisdictions, more submissions, and more complexity than ever before. Zelthy gives regulatory teams an intelligence layer — AI agents monitor requirement changes across jurisdictions, flag gaps in dossier readiness, automate document assembly, and keep submission pipelines visible. **Regulatory pipeline covered:** 1. Intelligence — AI-powered monitoring across health authorities. Automated change detection with portfolio impact analysis. Proactive alerts when requirements change for active products. 2. Planning — Unified submission pipeline across all authorities and products. Dependency mapping. Resource planning with workload visibility. AI-driven timeline predictions based on authority processing patterns. 3. Assembly — Centralised document repository with automated collection workflows. AI-powered gap analysis against authority-specific requirements. Real-time format validation for CTD and eCTD. Assembly time reduced from weeks to days. 4. Filing — End-to-end submission lifecycle tracking from filing through approval. Centralised authority interaction management. AI-assisted deficiency response drafting. Commitment tracking. 5. Maintenance — Automated post-approval lifecycle management. Global labelling change coordination across markets. AI-powered PSUR/DSUR generation. Renewal and variation tracking with proactive deadline alerts. **Templates:** Submission Management, Dossier Assembly (CTD/eCTD), Regulatory Intelligence, Health Authority Tracking, Labelling Management, Regulatory Reporting (PSUR/DSUR). **Production metrics:** 40% faster submissions · 8 health authorities tracked · 100% dossier gap visibility · Zero missed submission deadlines. - [45+ Pharma Use Cases: PSP, Traceability, CTMS | Zelthy](https://www.zelthy.com/use-cases): Pre-built templates and AI-powered application modules for patient services, advanced therapies, commercial operations, traceability, compliance, and regulatory affairs. 45+ pre-built use case templates across six verticals. Each use case module is a configurable application component with defined capabilities, AI integrations, and a description of what it replaces. AI-powered use cases are marked and include specific agent capabilities. Browse and explore by vertical: Patient Services, Advanced Therapies, Commercial Operations, Traceability, Compliance, Regulatory Affairs. ## Case Studies - [AI-Powered Regulatory Document Operations for a Top-10 Pharma — Zelthy Case Studies](https://www.zelthy.com/case-studies/ai-powered-regulatory-document-operations): AI agents deployed to streamline regulatory document operations for a global pharma company — faster operations, reduced costs, improved document quality. - [PSP Boosts Cancer Therapy Adherence in Australia — Zelthy Case Studies](https://www.zelthy.com/case-studies/cancer-patient-support-program): Zelthy-powered PSP drives 45% adherence improvement for cancer therapy patients in Australia. - [Digitizing Vaccine Ordering for a Leading Global Pharma — Zelthy Case Studies](https://www.zelthy.com/case-studies/digitizing-vaccine-ordering-for-a-leading-global-pharma): Digital vaccine ordering platform onboards 3,000+ clinics in 6 months for a leading global pharma. - [Product Tracking for a Global Pharma Giant — Zelthy Case Studies](https://www.zelthy.com/case-studies/product-tracking-supply-chain-global-pharma): Blockchain-powered end-to-end supply chain visibility — reduced stockouts and improved inventory turnover. - [Digitizing Compassionate Access Programs — Zelthy Case Studies](https://www.zelthy.com/case-studies/digitizing-compassionate-access-programs-for-a-leading-pharma-in-australia): Improved compassionate access approval times and reduced costs for a leading Australian pharma company. - [Scalable HIV Program Management for Public Health — Zelthy Case Studies](https://www.zelthy.com/case-studies/public-health-program-management): 1 million+ patient registrations, 500 centres live, zero downtime in two months. - [Complete Therapy Management for a Big Pharma Company — Zelthy Case Studies](https://www.zelthy.com/case-studies/complete-therapy-management-for-a-big-pharma-company): Improved patient adherence, satisfaction, and cost reduction with Zelthy's Complete Therapy Management suite. - [Direct-to-Patient Drug Delivery for Dialysis Patients — Zelthy Case Studies](https://www.zelthy.com/case-studies/direct-to-patient-drug-delivery): Monthly nephrology supply delivery to dialysis patients' homes with customised packages and real-time support. - [Pharma Case Studies: PSP, Traceability & More | Zelthy](https://www.zelthy.com/case-studies): Full library of production deployments across patient services, commercial operations, traceability, and compliance. ## Blog - [AI Compliance in Pharma: Regulatory Risks, Monitoring Frameworks, and Governance Models](https://www.zelthy.com/blog/ai-output-compliance-monitoring): Preventing risky AI outputs in pharma through continuous compliance monitoring and regulatory enforcement — 32 citations from FDA, EMA, and ICH guidance. - [Patient Support Programs 101: Why Pharma Runs PSPs in the US and EU](https://www.zelthy.com/blog/patient-support-programs-US-EU): Role and impact of Patient Support Programs including treatment persistence, regulatory compliance, and market access in the US and EU. - [How AI is Transforming Patient Support Programs in 2026](https://www.zelthy.com/blog/ai-patient-support-programs): Personalised care, predictive insights, and automation at scale in modern PSP operations. - [Unifying Multiple PSP Vendors Under One Data Layer](https://www.zelthy.com/blog/unifying-multiple-psp-vendors-under-one-data-layer): Unified data layers to boost patient adherence, cut operational costs, and reduce ER visits. - [How Traceability Transforms Pharma Business Models](https://www.zelthy.com/blog/how-traceability-transforms-pharma-business-models-from-compliance-cost-to-competitive-advantage): Pharmaceutical traceability as strategic advantage — efficiency, revenue growth, and competitive differentiation beyond regulatory compliance. - [Understanding Pharmaceutical Traceability: A Global Landscape](https://www.zelthy.com/blog/the-pharmaceutical-traceability-landscape): Global traceability maturity, GS1 standards, emerging tech, and strategic shift from compliance cost to competitive advantage. - [The Executive's Implementation Guide to Complete Traceability](https://www.zelthy.com/blog/the-implementation-guide-to-complete-traceability): Avoiding traceability pitfalls and implementing successful deployment strategies for pharma executives. - [What a CTMS Should Centralize in 2026](https://www.zelthy.com/blog/what-a-ctms-should-centralize): 10 critical things modern CTMS platforms must centralise to cut costs 30% and reduce timelines 6 months. - [Clinical Trial Management System: The Complete Guide](https://www.zelthy.com/blog/clinical-trial-management-system-the-complete-guide): Comprehensive guide to CTMS — benefits, core features, selection criteria, implementation, and trends. - [Expanded Access Basics: When and How Sponsors Should Offer It](https://www.zelthy.com/blog/expanded-access-basics): Regulatory pathway of expanded access (compassionate use) for patients with life-threatening diseases. - [AI-Powered Compliance Platform for Life Sciences | Zelthy](https://www.zelthy.com/blog/ai-powered-compliance-platform-life-sciences): The case for AI-powered compliance platforms in pharma — six capabilities, evaluation framework, and deployment pathway. Used by 6 of top-10 pharma. - [Patient Support Programs: A Guide for Pharma Leaders](https://www.zelthy.com/blog/what-are-patient-support-programs-a-complete-guide): Understand Patient Support Programs — from onboarding to AI-driven engagement — and why they're business-critical for patient outcomes and pharma performance. - [Global PSP Compliance Monitoring: Centralized Platform Guide](https://www.zelthy.com/blog/global-patient-program-monitoring-platform): How top pharma companies monitor multi-country PSPs: centralised datalakes, AI-driven policy enforcement, and real-time vendor oversight. 65% faster approvals. - [Complete Therapy Management: Product Tracking + PAP](https://www.zelthy.com/blog/complete-therapy-management): Merge pharma distribution tracking with patient assistance programs. AI-powered engagement drives 25% higher adherence and 40% better satisfaction scores. - [10 Strategies to Boost Clinical Trial Recruitment](https://www.zelthy.com/blog/boost-patient-recruitment-retention-clinical-trials): Proven strategies to overcome the 85% recruitment delay rate in clinical trials — digital outreach, decentralised models, and AI-powered engagement. - [Compliance & Documentation in Clinical Trials](https://www.zelthy.com/blog/compliance-and-documentation-clinical-trials-best-practices): Best practices for compliance and documentation in clinical trials to ensure accuracy, safety, and regulatory success. - [Accelerate Healthcare App Development with Zelthy Templates](https://www.zelthy.com/blog/custom-healthcare-application-templates): Zelthy's pre-built, HIPAA-compliant templates launch apps in a week, slash cloud spend by 50–70%, and give full customisation and open-source flexibility. - [Hospital Inventory Management Best Practices 2026](https://www.zelthy.com/blog/hospital-inventory-management-best-practices): Proven hospital inventory strategies to cut costs by 50% and reduce waste — automation, data analytics, and compliance best practices for 2026. - [Life Sciences & Pharma Tech Blog | Zelthy](https://www.zelthy.com/blog): Expert insights on patient support programs, pharma traceability, clinical trials, AI compliance, and digital operations. ## Events - [Zelthy at Pharma Compliance Congress 2026 | PCC](https://www.zelthy.com/pharma-compliance-congress): Meet Zelthy at PCC 2026. AI-native compliance intelligence for pharmaceutical companies — regulatory change mapping, continuous monitoring, AI compliance copilot, and purpose-built systems deployed in 4–8 weeks. **Event:** Pharma Compliance Congress (PCC) 2026. **What Zelthy showcases at PCC:** The Zelthy compliance intelligence platform — four AI-native layers covering regulatory change monitoring, continuous transaction monitoring, policy governance, and purpose-built compliance systems. The same platform used by 6 of the top-10 global pharma companies. **Four compliance layers demonstrated:** 1. Know — AI monitors regulatory sources continuously; maps every change to impacted SOPs and active programs; impact analysis in minutes. 2. Watch — 8 AI agents monitoring every business process transaction continuously. 100% coverage, not sampling. 3. Guide — AI copilot grounded in your actual policies; answers compliance questions with specific citations in 30 seconds. 4. Run — 75+ purpose-built compliance system templates deployed in 4–8 weeks with DOJ-aligned effectiveness measurement built in. **Contact:** Request a demo or book a meeting at PCC via the contact form on this page. ## Optional - [Privacy Policy — Zelthy](https://www.zelthy.com/privacy-policy): How Zelthy collects, uses, and protects personal data under GDPR and applicable privacy regulations. - [Terms of Service — Zelthy](https://www.zelthy.com/terms): Terms and conditions governing use of the Zelthy platform and services.