PharmaSignal AI
Government-pricing compliance for U.S. pharmaceutical manufacturers

Know what changed. Know what it means for your NDCs. Prove what you did about it.

The system of record for government-pricing compliance decisions. Every regulatory change classified for your NDC portfolio, tracked to its deadline, and provable to an auditor.

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Sound familiar?

None of these is a people problem. They are a system-of-record problem — and the process breaks silently, often for years.

Today

  1. A CMS proposed rule touches the AMP definition. Who decides whether it applies to your NDCs?
  2. OIG asks for evidence. The answer is in inboxes, SharePoint and three versions of a workbook.
  3. A deadline was created by a rule change; the spreadsheet didn’t escalate.
  4. “Reasonable assumptions” live in one or two people and a memo nobody can date. When they leave, the rationale leaves with them.

With PharmaSignal AI

  1. Every change classified against your own NDC portfolio, with a Deep Dive and a tracked action plan.
  2. Every decision on an INSERT-only, immutable ledger; evidence bundles with approval.
  3. Deadlines auto-populated from program templates, linked to the change that created them.
  4. Reasonable assumptions registered and scored; methodology updates director-approved.
How it works

Watch. Decide. Prove.

One system of record, in the order a government-pricing team works.

Watch

Every U.S. regulatory source that moves your obligations, each change classified against your own NDC portfolio.

Explore Watch

Decide

Methodology updates proposed, director-approved and sent as structured change orders.

Explore Decide

Prove

Every decision on an INSERT-only, immutable ledger. Answer the auditor from the record.

Explore Prove
PharmaSignal AI

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.

Where it sits

Above the systems you already run — never replacing them.

Your calculation system computes whatever methodology it is configured with. PharmaSignal AI is where that methodology is decided, approved and handed over.

Where PharmaSignal AI sits: above the calculation system and the ERP U.S. regulatory sources — federal agencies, the Federal Register, state and program sources, and any source added to the registry — flow into PharmaSignal AI — Watch, Decide, Prove — the decision-and-evidence layer. Approved methodology changes flow down to the calculation system and the ERP you already run as structured change orders; customer master, transactions and WAC events are read back from the ERP; evidence goes out to auditors, outside counsel and OIG as response packs and a read-only portal; CMS submission status, HRSA OPAIS, First Databank, Medi-Span and Red Book are read for reconciliation, never written. U.S. regulatory sources — federal, state, programCMS Federal RegisterFDA CDERCMS MDRPDOJ FCAHHS OIG340BFDA Manufacturer NoticesState Medicaid+ any sourcemonitored, classified against your NDC portfolioPharmaSignal AIWatch · Decide · Provethe decision-and-evidence layer — never calculates, never submitsstructured change orders, verified implementationcustomer master, transactions,WAC events (read)Systems you already run — never replacedCalculation systemModel NIntegriChain ICytein-houseERPSAPOracleEvidence outauditors · outside counsel · OIGresponse packs, read-only portalReconciliation readsCMS · HRSA OPAISFirst Databank · Medi-SpanRed Book — read, never written U.S. regulatory sourcesCMS Federal RegisterFDA CDERCMS MDRPDOJ FCAHHS OIG340BFDA Manufacturer NoticesState Medicaid+ any sourcemonitored, classified againstyour NDC portfolioPharmaSignal AIWatch · Decide · Provethe decision-and-evidence layer —never calculates, never submitsstructured change orders,verified implementationcustomer master, transactions,WAC events (read)Systems you already runCalculation systemModel NIntegriChain ICytein-houseERPSAPOracleEvidence outauditors · outside counsel · OIGresponse packs, read-only portalReconciliation readsCMS · HRSA OPAIS · First DatabankMedi-Span · Red Book — read, never written
Where PharmaSignal AI sits: above the calculation system and the ERP U.S. regulatory sources — federal agencies, the Federal Register, state and program sources, and any source added to the registry — flow into PharmaSignal AI — Watch, Decide, Prove — the decision-and-evidence layer. Approved methodology changes flow down to the calculation system and the ERP you already run as structured change orders; customer master, transactions and WAC events are read back from the ERP; evidence goes out to auditors, outside counsel and OIG as response packs and a read-only portal; CMS submission status, HRSA OPAIS, First Databank, Medi-Span and Red Book are read for reconciliation, never written. U.S. regulatory sources — federal, state, programCMS Federal RegisterFDA CDERCMS MDRPDOJ FCAHHS OIG340BFDA Manufacturer NoticesState Medicaid+ any sourcemonitored, classified against your NDC portfolioPharmaSignal AIWatch · Decide · Provethe decision-and-evidence layer — never calculates, never submitsstructured change orders, verified implementationcustomer master, transactions,WAC events (read)Systems you already run — never replacedCalculation systemModel NIntegriChain ICytein-houseERPSAPOracleEvidence outauditors · outside counsel · OIGresponse packs, read-only portalReconciliation readsCMS · HRSA OPAISFirst Databank · Medi-SpanRed Book — read, never written U.S. regulatory sourcesCMS Federal RegisterFDA CDERCMS MDRPDOJ FCAHHS OIG340BFDA Manufacturer NoticesState Medicaid+ any sourcemonitored, classified againstyour NDC portfolioPharmaSignal AIWatch · Decide · Provethe decision-and-evidence layer —never calculates, never submitsstructured change orders,verified implementationcustomer master, transactions,WAC events (read)Systems you already runCalculation systemModel NIntegriChain ICytein-houseERPSAPOracleEvidence outauditors · outside counsel · OIGresponse packs, read-only portalReconciliation readsCMS · HRSA OPAIS · First DatabankMedi-Span · Red Book — read, never written
PharmaSignal AI records the methodology and the evidence. It does not calculate AMP, Best Price or URA, and it does not submit to CMS.

How it fits your stack

Trust

Built for regulated environments

Designed for HIPAA-regulated operationa design fact, not a certification
Per-tenant isolationRow-Level Security, tenant context
SSO / SAMLper-tenant IdP, group-to-role mapping
Governed, human-in-the-loop AIclosed-vocabulary validation, provenance

Trust on the Product page

See the whole picture. Decide with the evidence in hand.

A working conversation about your portfolio, your calculation system and your next audit.

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Building the Methodology Workbench with a few manufacturers — become a design partner.