6 capabilities
Watch
See every change that touches your portfolio
- Regulatory Source Monitor
- AI-assisted classification
- Human Review Queue
- Alert Dashboard
- Source Document Viewer
- Regulatory Basis Watch
Government-pricing compliance for U.S. pharmaceutical manufacturers
The four jobs of a government-pricing team, in one system of record.
Watch every source that moves your obligations. Decide what each change means for your NDCs and your methodology. Prove it to an auditor from the record. Connect it to the systems you already run.
Your day as
The problem
A day in government pricing
Three moments every team knows — and what changes with a system of record.
A rule with portfolio impact lands
Today:A CMS proposed rule touches the AMP definition. Who decides whether it applies to your NDCs?With PharmaSignal AI:Classified against your NDC portfolio; a Deep Dive with exposure tier and enforcement cases.An evidence request arrives
Today:OIG asks for evidence on one product family. The answer is in inboxes, SharePoint and a workbook.With PharmaSignal AI:One click returns the detection → approval → implementation timeline, from the ledger.A deadline nobody linked to its rule
Today:A reporting deadline was created by a rule change. The spreadsheet didn’t escalate.With PharmaSignal AI:Deadlines auto-populated from program templates, linked to the change that created them.
1 · Watch
See every change that touches your portfolio
Regulatory Source Monitor
Federal, state and program sources on one extensible registry; scheduled monitoring, visible source health.
AI-assisted classification
Every change classified against your own NDC portfolio.
Human Review Queue
Low-confidence classifications stop and flag rather than apply silently.
- Your day — GP Director
- Portfolio-relevant alerts instead of agency digests, on a visible monitoring schedule.
- Your day — Compliance Manager
- Low-confidence calls stop in the Human Review Queue rather than apply silently.
- Your day — GP Analyst
- One portfolio-filtered queue instead of 10–50 digest items a day.
- Your day — Tenant Admin
- Source health and crawl scheduling visible to administrators.
2 · Decide
Methodology and reasonable assumptions, director-approved
Deep Dive
Exposure tier, comparable enforcement cases, a tracked action plan.
Assumption Registry
Registration with approval; a Defensibility Risk Score per assumption.
Methodology Workbench
AI-generated proposal → structured review → GP Director approval → structured output.
NDC Portfolio
Auto-populated from your FDA labeler codes; drug classification with justification and a review record — recorder and approver never the same person.
- Your day — GP Director
- The exposure tier and enforcement context before a methodology decision; assumptions you can sign your name to — and the IRA inflation-rebate dispute window on the calendar, escalated before it closes.
- Your day — Compliance Manager
- Enforcement cases inside each Deep Dive; a Defensibility Risk Score on every registered assumption.
- Your day — GP Analyst
- AI-drafted update proposals, structured review, structured change orders — no re-typing into the calculation system.
- Your day — Tenant Admin
- PharmaSignal AI sends the specification; nothing is written to Model N or IntegriChain without a person confirming it.
3 · Prove
Answer the auditor from the record
Immutable audit ledger
Every decision on an INSERT-only, immutable audit ledger.
“When Did You Know, What Did You Do?” Query
One click returns the detection → approval → implementation timeline.
OIG Audit Response Pack
The response pack in multiple formats.
- Your day — GP Director
- Approvals as signed ledger events; Quarterly Compliance Certification by the GP Director.
- Your day — Compliance Manager
- Same-day answers from the record, self-contained for a third party.
- Your day — GP Analyst
- The reasoning captured where the work happens — provenance on every AI-generated summary.
- Your day — Tenant Admin
- Tenant-scoped audit read; a time-limited, scope-limited External Auditor Portal.
4 · Connect and anticipate
Fit the stack you run — and see trouble coming
Calculation Impact Map
Calculation Matrix, regulatory-change overlay, Cascade Visualizer, Methodology Delta View.
Enforcement Intelligence
Every settlement, action and decision classified by root cause; Proactive Pattern Alert.
Planned integrations
Model N, IntegriChain ICyte, SAP / Oracle ERP read, outbound webhooks.
- Your day — GP Director
- The cascade from AMP to URA to 340B ceiling price; a Tenant Risk Profile; a Proactive Pattern Alert when a settlement mirrors your position.
- Your day — Compliance Manager
- Every settlement and action classified by root cause and affected calculation.
- Your day — GP Analyst
- Structured change orders for Model N or IntegriChain instead of hand transcription.
- Your day — Tenant Admin
- The integration model you already run, by name.
Planned integrations are named nominatively; PharmaSignal AI has no partnership or certification with the vendors named.
5 · The AI layer
The AI reads the regulation. You keep the decision.
Assisted, never autonomous — every AI call goes through one governed gateway, and every output carries its provenance.
Reads and classifies
A regulation that forces a methodology change looks identical, at publication, to one that is informational. Every change is classified against your own NDC portfolio, with an AI confidence on each call.
Summarizes and interprets
What changed, what it means, what to do — down to AMP, Best Price and URA mechanics.
Flags what it isn’t sure about
Low-confidence calls stop in the Human Review Queue; open questions are named, not guessed.
Proposes, never decides
AI-drafted assumptions and methodology updates, labelled until a person edits; the GP Director approves.
Anticipates enforcement
Every settlement and action classified by root cause; a Proactive Pattern Alert when one mirrors your position.
Shows its work
Provenance on every output; one governed inference gateway; no direct model calls.
The whole picture
Everything in the platform
Every capability, by the job it serves — the whole platform on one screen. The detail is in the demo.
6 capabilities
Decide
Methodology and reasonable assumptions, director-approved
- Deep Dive
- Compliance Calendar
- NDC Portfolio
- Assumption Registry
- Living Methodology Policy Document
- Methodology Workbench
11 capabilities
Prove
Answer the auditor from the record
- Immutable audit ledger
- Audit Evidence
- Recorder / approver separation
- AI provenance
- Immutable Event Ledger
- Digital Signature
- “When Did You Know, What Did You Do?” Query
- OIG Audit Response Pack
- CIA Compliance Mode
- External Auditor Portal
- Audit-trail search and anomaly detection
7 capabilities
Connect and anticipate
Fit the stack you run — and see trouble coming
- Calculation Impact Map
- Financial sensitivity analysis
- Enforcement Intelligence
- Planned integrations
- Contract Structure Registry and Distribution Channel Mapping
- Enterprise tenant administration
- AI capability layer
7 capabilities
Trust
Built for regulated environments
- Designed for HIPAA-regulated operation
- Per-tenant Row-Level-Security isolation
- SSO via Auth0 with per-tenant SAML
- Role and permission customization
- Governed inference gateway
- PHI-handling boundaries
- Nine-module modular monolith on AWS with Aurora PostgreSQL
These are design facts about the platform. PharmaSignal AI does not claim a certification or attestation it does not hold.
Shape the Methodology Workbench — become a design partner
Early access, and a direct line into the Workbench’s design.
Prove it to an auditor from the record.
A working session on your portfolio, your programs and the system you calculate in.
Building the Methodology Workbench with a few manufacturers — become a design partner.