Regaldi embeds artificial intelligence inside the regulated workflow, not above it. The assistant listens, transcribes, drafts, reconciles, and projects, so the licensed professional moves faster and misses nothing. It prepares the work. It does not decide the work, and it never signs.
READ THIS FIRST The assistant operates on the data and configuration a facility supplies, and it supports, rather than replaces, the facility’s licensed personnel. Where a step is governed by regulation, the human reviews, decides, and signs, attributable under 21 CFR Part 11. Machine assistance is applied at selected control points, not at every surface, to keep the validation surface defensible. Machine assistance does not confer FDA approval, clearance, or an inspection history.
Every row below is a moment an operator already lives. The assistant takes the part that rewards doing the same thing the same way every time, and hands back the part that requires judgment. These are functions of the running systems, fitted to the operation that uses them.
Nothing the assistant drafts advances a regulated step on its own. The phase gate, the second-verifier signature, and the Pharmacist-in-Charge release described in the compliance ledger are unchanged. The assistant fills the form and lays the evidence beside it. The licensed professional reads it, corrects it, and signs it. That order is the product.
Simplification of process comes first. Then automation. Then machine assistance, and only where the first two fall short of the standard. Assistance is placed at named control points, not spread across every screen, so the validation surface stays small enough to defend and the signature discipline stays intact.
The model drafts and surfaces. It does not interpret the regulation. Where a rule governs a step, the assistant cites the controlled source and lays it in front of the licensed human, rather than reading it for them. Which rules are categorical and which call for judgment is configured with the client’s quality unit, not decided for them.
A pharmacy does not run on compliance alone. It runs on prescribers who call back and orders that arrive. Regaldi operates the commercial side with the same instruments: AI-assisted acquisition, automated correspondence, and a direct-outreach base of more than one hundred thousand physicians and clinics, fed into the CRM the dispensing floor already runs on. We do not just build the system of record. We fill it.
One hundred thousand is the reach of the outreach base, not a count of customers. The figures above the line are from a seventeen-year compounding pharmacy, in daily production.
No. It prepares records and surfaces information. Every clinical judgment, every verification, and every release decision is made and signed by licensed personnel, attributable under 21 CFR Part 11. The assistant fills the form; the licensed professional reads it, corrects it, and signs it.
The system it sits inside follows a GAMP 5 validation approach; the validation package is authored, and its execution precedes commercial activation at each facility. Machine assistance is confined to named control points rather than spread across every screen, so the validation surface stays defensible, and every output is reviewed by a person before it enters the record. This is software validation, not FDA approval or clearance.
The assist layer is model-neutral. Regaldi selects and changes models per task as the field moves. The discipline does not change with the model: the assistant drafts and surfaces, the licensed human reviews and signs.
Yes. The assistant is fitted to the operation’s own standard operating procedures and the CRM or ERP it already runs on, rather than imposed as a fixed template. Adoption does not require revalidating the way the operation already works.
Regaldi will walk the director of pharmacy and the Pharmacist-in-Charge through where machine assistance fits a specific operation, which control points it touches, and where the signature stays with the licensed human. We come from the floor we are building for, and we keep the judgment with the professional who carries the consequence.