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

Why a system of record — and not another feed.

Manufacturers already get the digests. The question is not “are we compliant?” — it is “how would we know if we weren’t?” The answer needs the place where the decision, the reasonable assumption, the methodology and the evidence live together, versioned and approved.

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Sound familiar?

Today

  1. Digests arrive as 10–50 headline items a day; someone decides applicability by hand.
  2. The impact memo is drafted from scratch; nobody records who decided, or why.
  3. “Reasonable assumptions” live in one or two people and a memo nobody can date. When they leave, the rationale leaves with them.
  4. “Why was NDC X classified this way two years ago?” takes days to answer.

With PharmaSignal AI

  1. Every U.S. regulatory source that moves your obligations — federal, state and program — monitored on a visible schedule; each change classified against your own NDC portfolio.
  2. A Deep Dive per change — exposure tier, comparable enforcement cases, a tracked action plan.
  3. Reasonable assumptions registered and scored; methodology updates proposed, director-approved, sent as structured change orders.
  4. Every decision on an INSERT-only, immutable ledger; the “When Did You Know, What Did You Do?” Query answers in one click.

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

Why it holds up

A system of record, not a feed

Decisions, assumptions and methodology in one versioned, approved, auditable place.

Separation of duties built in: recorder / approver split with narrative justification; GP Director approval as the authorized-signatory record — not a reply-all.

Portfolio-aware, deadline-aware

Every change scored against your NDC portfolio; deadlines linked to their cause.

Bi-temporal portfolio history behind every classification; calendar events auto-populate from program templates and connect to the changes and action items that created them.

Enforcement context everywhere

Comparable DOJ/FCA, OIG and state-AG cases beside every Deep Dive.

Human-in-the-loop AI: a Human Review Queue, closed-vocabulary validation, provenance on generated content, no direct model calls.

Closes the loop with the calculation system

Approved methodology changes leave as structured change orders, not emails.

Verified implementations in Model N or IntegriChain; an immutable audit ledger with a seven-year retention floor, queryable as “When Did You Know, What Did You Do?”. PharmaSignal AI sends the specification. It does not calculate AMP, Best Price or URA.

Where PharmaSignal AI sits

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.

Product names are used nominatively; PharmaSignal AI has no partnership or certification with the vendors named.

Will an auditor accept it?

Immutable ledger

INSERT-only, with a seven-year retention floor — beyond the six-year HIPAA documentation-retention requirement (45 CFR §164.530(j)).

Evidence bundles

Create → approve → export, with anti-rubber-stamp safeguards.

Response pack

The OIG Audit Response Pack and a time-limited, scope-limited External Auditor Portal.

Built for regulated environments

  • Designed for HIPAA-regulated operation
  • Per-tenant isolation
  • SSO / SAML
  • Role governance
  • Governed inference gateway
  • PHI-handling boundaries
  • AWS · Aurora PostgreSQL

These are design facts about the platform. PharmaSignal AI does not claim a certification or attestation it does not hold.

Trust on the Product page

Decide with the record, not from memory.

Bring your portfolio and your calculation system; we’ll walk the four jobs against your next audit cycle.

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