Orchestrate every step of cell, gene & complex drug therapies on one audit‑ready platform
From referral to long‑term outcomes, Zelthy unifies scheduling, chain‑of‑identity, safety, and reimbursement so teams hit life‑saving timelines—not roadblocks.
The Enterprise Challenge
Disjointed tooling
Teams juggle CRMs, courier portals, LIMS, and spreadsheets, delaying onboarding by weeks.
Chain‑of‑identity
Risk grows with every manual hand‑off between apheresis sites, CMOs, and treatment centers.
Regulators demand proof
(21 CFR Part 11, EMA GMP Annex 13, GDPR) of every decision and timestamp.
What You Get
Option - Pre-built Apps
Best For - Rapid CAR‑T & gene‑therapy launches
What you get - SOP‑aligned templates, chain‑of‑identity tracker, REMS module
Option - Option - AI Agents
Best For - Automating critical coordination
What you get - Delay‑prediction bot, capacity‑balancing bot, automated deviation summarizer
Option - Custom Apps
Best For - Novel therapy models
What you get - Low‑code builder for bespoke workflows & data‑models
Security & Compliance
- GxP & 21 CFR Part 11 validation
- ISO 27001 & SOC 2 Type II certified
- HIPAA & GDPR privacy controls
- Regional data residency options (EU, US, APAC)
Zelthy Operating System for Therapies
AI Insights Layer
- Predicts vein‑to‑vein delays and recommends rescheduling before conflicts occur.
- Flags temperature‑excursion risk via courier telemetry.
- Generates real‑world‑evidence dashboards trusted by medical affairs.
Pre-built workflows
Referral intake, slot booking, release testing, adverse‑event reporting, REMS
Real-time status boards
Live chain‑of‑identity & custody, capacity heat‑maps
Interoperability APIs
HL7 FHIR & GS1 EPCIS connectors to EHRs, LIMS, couriers
Secure data lake
Region‑aware, fully encrypted clinical & manufacturing data
Challenge
Three vendors and six tools caused 4‑week onboarding delays.
Solution
Zelthy deployed therapy‑management workspace plus AI capacity agent in 8 weeks.
Impact
30 % faster onboarding, 25 % fewer scheduling conflicts, 50 % reduction in audit findings.
Ready to see therapy management in action ?
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