Government-pricing compliance for U.S. pharmaceutical manufacturers
Built by government-pricing people, for government-pricing people.
PharmaSignal AI exists because the people who sign methodology decisions deserve a system of record — not a feed, a spreadsheet and a memo.
The company
Who we are
PharmaSignal AI is the system of record for government-pricing compliance decisions — the place where the regulatory watch, the decision, the reasonable assumption and the audit evidence live together.
Our team has spent about twenty years inside pharmaceutical Commercial and Government Pricing Revenue Management, building the systems that compute and report AMP, Best Price, URA, Non-FAMP, ASP and the MDRP, 340B and FSS / Big4 obligations behind them. We build PharmaSignal AI with government-pricing practitioners and with a small number of manufacturers as design partners.
- Assisted, never autonomous — a person keeps every decision.
- Designed for HIPAA-regulated operation — a design fact, not a certification.
- Built with practitioners — design partners shape the Methodology Workbench.
- Above the systems you run — never replacing the calculation engine or the ERP.
Why PharmaSignal AI exists
Three gaps, confirmed in product-validation interviews.
No versioned methodology and reasonable-assumptions record
Answered by DecideNo audit-evidence packaging
Answered by ProveFrom evaluation to operation
How we work with you
The path a manufacturer’s evaluation actually runs — sponsor, security, legal and procurement — and what we bring to each step.
A working demo on your portfolio
Your programs, your calculation system, your hardest audit question — not a canned tour.
Security and architecture review
We answer your vendor risk questionnaire and walk your security team through the architecture.
Design partnership or pilot
Build against your own portfolio; shape the Methodology Workbench with early access and a direct line into its design.
Implementation with the systems you run
Your calculation system and your SSO, connected in the order your team works.
A named team, through go-live and beyond
One team from evaluation to operation — no hand-off to a queue.
How we build
A compliance buyer should never have to guess what is real.
AI is assisted, never autonomous: a Human Review Queue, closed-vocabulary validation, provenance on every generated summary, a director’s approval on every methodology change.
Designed for HIPAA-regulated operation from the first line: per-tenant isolation, an INSERT-only audit ledger with a seven-year retention floor, PHI-handling boundaries.
We work with a small number of design partners on the Methodology Workbench.
For your security and procurement teams
Built for the security review
What we bring to your vendor risk assessment — the architecture, documented, and a team that walks the review with you.
Security architecture
Per-tenant Row-Level-Security isolation plus application-layer tenant context; SSO via Auth0 with per-tenant SAML.
Data flow and PHI boundaries
Where data lives, how it moves, PHI-handling boundaries with log redaction.
The audit-ledger design
INSERT-only and immutable — enforced by a database trigger, not only by the application — with a seven-year retention floor beyond the six-year HIPAA documentation-retention requirement.
AI governance
Every AI call through one governed inference gateway; closed-vocabulary validation; provenance on every output.
Access and role governance
Role and permission customization with sensitive-grant confirmation; user lifecycle management.
Retention and change control
A retention policy catalog and versioned, traceable specifications behind every release.
These are design facts about the platform. PharmaSignal AI does not claim a certification or attestation it does not hold.
See it against your portfolio.
A working session with the PharmaSignal AI team — bring your portfolio and your hardest audit question.
Building the Methodology Workbench with a few manufacturers — become a design partner.