Meet Zelthy at the Pharmaceutical Compliance Congress (PCC 2026) in McLean, Virginia|April 27–29|Booth 25.Meet Zelthy at the Pharmaceutical Compliance Congress (PCC 2026) in McLean, Virginia|April 27–29|Booth 25.
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The AI platform
for pharma compliance.

Six AI-powered capabilities — regulatory mapping, continuous monitoring, policy governance, AI copilot, purpose-built systems, and transparency reporting. One platform. Deployed in weeks.

Compliance Coverage
Live
100
%
of transactions monitored. Continuously.
75+ use cases · 12 domains · 4–8 wk deploy
Capabilities
KnowWatchBuildGuideRunReport
75+
Compliance
use cases
4–8 wk
To full
deployment
100%
Transaction
coverage
90%
Faster impact
analysis
Trusted by
AstraZenecaMerckRocheBMSNovo Nordisk
Know

Regulation changes.
Impact surfaces instantly.

AI maps every regulatory update against your complete policy corpus, identifies every impacted SOP and active program, and assigns action items to the right owners — automatically.

90%
Faster impact analysis
Zero gaps
In regulatory change tracking
Minutes
Not weeks to assign owners
OIG2 min ago
OIG Advisory 26-03: Anti-Kickback Safe Harbor for PAPs
Updated guidance on free goods distribution and copay assistance programs.
EFPIA4 hrs ago
EFPIA Code 2026 — HCP Congress Hospitality Limits
Revised hospitality caps for EU markets across Germany, France, and UK.
FDA1 day ago
FDA Warning: Promotional Compliance in Digital Channels
Enforcement action on off-label claims in social and digital media.
Impact — OIG Advisory 26-036 items
Policies & SOPs
PAP Eligibility Policy — GlobalNeeds update
SOP-042: Free Goods DistributionNeeds update
SOP-018: HCP Referral DocumentationReview
Active programs
Oncology PAP — APAC/SEAEligibility
Cardiology Access — USCopay structure
Auto-generated actions
Update PAP Eligibility Policy — safe harbor criteria→ J. Martinez
Revise SOP-042 — free goods limits→ S. Chen
Review Oncology PAP — new thresholds→ R. Patel
Watch

AI agents monitoring every business process for compliance risk.

Eight specialized modules. Data flows in from your existing systems. Intelligence flows out. Not sampling — continuous monitoring of every transaction.

100%
Transaction coverage
60%
Fewer false positives vs rules engines
Always
Audit-ready — zero manual prep
Data sources
Veeva CRM
SAP Concur
Salesforce
Cvent
IQVIA
Grants mgmt
PSP ops
Compliance Intelligence EngineLive
PSP conduct
HCP engagement
Speaker programs
Aggregate spend
Access programs
Cross-system anomaly
AE capture rates
Sample accountability
Output
HCP spend alert
Threshold exceeded
Pattern flagged
Repeat attendee
AE capture alert
Below threshold
Case created
Auto-assigned
Audit package
Q1 compiled
Build

Policies and programs governed at the pace regulations demand.

AI-drafted policies mapped to regulatory triggers. Version-controlled SOP lifecycles with auto-review. Program governance workflows from inception to sunset.

Weeks
From regulation to updated SOP
100%
Lifecycle coverage — inception to sunset
Zero
Orphaned policies or expired SOPs
Policy lifecycle managementAI-assisted
Central repository with version control, authoring workflows, multi-level approvals, and periodic review triggers. When a regulation changes, impacted policies surface automatically.
SOP revision workflowsAuto-review
Regulatory triggers initiate SOP reviews. AI drafts revision recommendations. Approval chains route to the right owners. Full audit trail of every change.
Program governancePSP · REMS · Grants
Every program — PSP, PAP, REMS, grants, donations, sponsorships — reviewed against Anti-Kickback and local requirements before launch. Risk flagged at inception.
Policy impact analysisConnected to Know
When Know detects a regulatory change, Build identifies every impacted policy, SOP, and training material. Change impact reports and action items generate automatically.
Guide

Compliance guidance in the moment it's needed.

Grounded in your actual policies. The AI copilot answers with specific citations, flags risks in context, and routes complex questions to the right compliance lane — automatically.

30 sec
Average policy answer time
80%
Queries resolved without escalation
0 generic
Every answer cites your policies
AI Compliance Copilot
I'm hosting a dinner for 8 HCPs at the cardiology congress in Munich. One attendee is on the formulary committee. Can I proceed?
Formulary committee member flagged.

Dinner is within Germany meal cap (€60/person), compliant under EMEA-ENG-2024 §3.1. However, §4.2 requires pre-approval from Regional Compliance Officer for formulary decision-makers during active windows.

Next step: Submit pre-approval request.EMEA-ENG-2024 §4.2, §3.1
EMEA-ENG-2024
§3 Meal & Hospitality

3.1 — Meals at events must not exceed per-person caps. DE: €60. FR: €50. UK: £75.

§4 Formulary Decision-Makers
4.2 — Pre-approval required from Regional Compliance Officer for all formulary decision-makers during active assessment windows.
Status

⚠ Pre-approval required

Run

Purpose-built compliance systems. Configured to your rules. Live in weeks.

75+ pre-built use cases across every compliance domain. Configure any system to your exact requirements — without building from scratch.

75+
Pre-built compliance use cases
4–8 wk
From config to go-live
12
Compliance domains covered
Audit managementMost deployed
Internal audit scheduling, fieldwork, findings, CAPA tracking, and regulator-ready packages.
4–6 wk
CAPA management
Root cause analysis, corrective action workflows, effectiveness checks, and recurrence prevention.
4–6 wk
Activity risk assessment
New launches, market entries, third-party engagements, and sponsorship risk scoring.
4–6 wk
COI disclosures
Annual and event-triggered conflict of interest disclosures, review workflows, and mitigation tracking.
4 wk
Outside activity approvals
Speaking, consulting, advisory board participation. Risk and conflict-of-interest screening.
4 wk
Compliance calendar
All deadlines — submissions, audits, SOP reviews — in one place with auto-escalation.
2–4 wk
Field compliance monitoring
Conduct, interaction quality, material adherence, and escalation workflows for field force.
6–8 wk
Market risk scoring
Country CPI, enforcement history, third-party density. Prioritize audit resources intelligently.
4 wk
75+
Compliance-ready AI-native systems
Configure any use case in weeks.
Report

Transparency reporting and third-party screening — automated.

Aggregate spend, HCP transparency, and sanctions screening running continuously. No manual compilation. No missed deadlines. No surprises at audit time.

Real-time
OIG / OFAC / sanctions screening
Always on
Aggregate spend aggregation
Zero
Manual report compilation
Sanctions & exclusion screeningReal-time
Continuous OIG, OFAC, FDA debarment, and global sanctions screening. Every HCP, vendor, and third party — screened on every interaction, not just onboarding.
Aggregate spend & transparencyAutomated
Sunshine Act, EFPIA Disclosure, and Open Payments aggregation across all markets. Automated reconciliation, exception management, and regulatory submission packages.
Third-party risk monitoringContinuous
Distributor, contract sales, CRO, and vendor conduct monitoring. Risk scoring updated continuously. Escalation and remediation workflows built in.

From assessment to ownership.

Every engagement starts with your compliance reality — what's manual, what's missing, where inspections have found gaps. We deploy, optimize, and transfer ownership.

01 · Assess
1–2 wk
Map your regulatory obligations, audit trail gaps, SOP lifecycle issues, and monitoring workflows against your specific compliance landscape.
02 · Deploy
4–8 wk
Configure and deploy the domains you need — monitoring agents, policy governance, compliance copilot, operational systems. Integrated with your existing stack.
03 · Optimize
Ongoing
Tune monitoring rules, reduce false positives, expand coverage to new business processes, and adapt to regulatory changes — continuously.
04 · Own
Progressive
Built on Zango — open-source Django. Your team can read, modify, and extend every line. Full code ownership. No vendor lock-in.
Connects to your existing stack
Veeva CRMVeeva VaultSAP ConcurSalesforceCventIQVIAOracleMedidata RaveSnowflakeSharePointDocuSignREST API · SFTP · Webhooks
Case study — Global top-10 pharma
Compliance visibility into patient support programs across 12+ markets — deployed in 6 weeks.
Zelthy deployed a program governance platform for a global top-10 pharmaceutical company. The compliance team now reviews every program brief against Anti-Kickback and local regulatory requirements before launch, monitors conduct continuously, and maintains always-current audit packages across all markets — without adding headcount.
6 wk
To full deployment
100%
Program coverage
Real-time
Risk visibility
12+
Markets, one platform
FAQ

Frequently asked questions

Get started

See compliance intelligence,
working.

Talk to our compliance team. We'll map your compliance landscape, show you a working module, and scope a pilot in your environment.

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