Regaldi AI LLC is a Florida-registered, manager-managed limited liability company. Every engagement is led by a principal and remains under principal supervision through release.
Regaldi pairs two disciplines that are rarely held by the same firm: the engineering and business architecture that makes a system scale, and the operating pharmacy experience that knows what an inspector will examine on day one. In a Regaldi build, the rules are encoded by people who work under those rules themselves. That pairing, not either discipline alone, is the practice.
Adam Sarman is Managing Member and Chief Executive Officer of Regaldi AI LLC. He holds an MBA and a bachelor's degree in engineering, and has spent two decades building and scaling operating businesses. Across every Regaldi engagement he leads the business architecture, systems strategy, scaling, sales, and operational-workflow design that lie between the regulation and the workable production system. He is the principal responsible for engagement letters, scope definition, the commercial and operational architecture of each client engagement, and the design of the sales and marketing operations through which medication-selling pharmacies actually reach prescribers and patients.
Where the engagement is the rebuild of an operating pharmacy, Adam leads the audit of the existing software estate, the business-process simplification that precedes automation, and the prescriber- and patient-facing workflow design that converts compliance discipline into measurable operational gain.
“Every engagement letter, scope definition, and architecture plan issued by this practice is issued under my review.”
Veronica Taran is a Principal of Regaldi AI LLC and a Florida-licensed pharmacist with more than three decades in practice. On every Regaldi engagement she holds the regulated side: USP General Chapters <797>, <795>, and <800> conformance; 21 CFR Part 11 record-and-signature architecture; cGMP-aligned operations; multi-signature release discipline; environmental-monitoring binding; and the day-to-day compounding-operations workflow that underlies sterile and non-sterile production at scale.
Where the engagement is a ground-up architecture for a 503B outsourcing facility, Veronica leads the regulated-workflow design, the compounding-record state machine, the Pharmacist-in-Charge release authority, and the inspection-readiness posture that any state Board of Pharmacy or FDA inspector will examine on day one.
“No release workflow leaves this practice until I have walked it as the pharmacist who would have to sign it.”
Regaldi is a two-principal Florida practice that designs, builds, and validates computerized systems for FDA-inspected pharmaceutical operations. The practice accepts engagements nationwide, working under each state Board of Pharmacy's applicable framework and the federal regulations that govern pharmaceutical software (21 CFR Parts 210, 211, and 11; USP General Chapters <797>, <795>, and <800>; Section 503B of the Federal Food, Drug, and Cosmetic Act). Engagements take two forms: an extension-of-team role within an operating pharmacy, in which Regaldi audits and remediates the existing software estate against current SOPs and Board of Pharmacy expectations; and a ground-up architecture role for a pre-launch outsourcing facility, in which Regaldi delivers the systems-of-record required to operate under Section 503B.
Compliance should not live only in a department, surfaced once a quarter; in a Regaldi build it is engineered into the workflow itself, where the governing regulation is present at the point of action rather than left to a binder, a quarterly audit, or memory, while accountability remains with the pharmacist and the quality unit. The practice builds on two proprietary platforms: a CRM for the commercial and dispensing operation, and an ERP for the production floor. Each is fitted to the client's own validated SOPs and workflows rather than imposed as a fixed template, so adoption does not require revalidating the way the operation already works.
At the point of action, the operator is shown the rule that governs the step and the record that satisfies it. Where a rule is categorical, the software enforces it as configured: the step does not advance until its conditions are met and recorded, or an authorized exception is logged to the audit trail. Where a rule calls for judgment, the system surfaces the governing provision and the relevant record to the licensed pharmacist, citing the controlled source rather than interpreting it. Which rules are treated as categorical and which as matters of judgment is configured with the client's quality unit, not decided for them.
The software performs the part that rewards consistency (checking every condition, on every batch, without lapse) and reserves to the licensed pharmacist the part that requires judgment. It does not exercise the judgment, hold the signature, or assure the outcome: the decision, the signature, and the regulatory responsibility remain the licensed human's, attributable as 21 CFR Part 11 requires. The governing regulation is recorded alongside each action: who acted, when, from which workstation, against which Master Formulation Record version, with which environmental-monitoring sample bound to the session. The production history is therefore inspection-ready as a byproduct of the work, not a reconstruction after it.
Every engagement opens with a written process and compliance audit, agreed with the client before code is written: every gap against the operating SOPs and the applicable USP chapters, every Part 11 control absent or under-implemented in the existing estate, and every documented deviation not yet closed. The deliverable is an architecture and remediation plan. Simplification of process precedes automation; automation precedes machine-learning support, which is added only where simplification and automation are insufficient to meet the standard.
Regaldi does not staff offshore body-shop teams, does not deliver through subcontractors of subcontractors, does not place engagements on a retainer panel, and does not engage outside FDA-regulated pharmaceutical operations. The engineering is done in-house by a staff of seventeen employed alongside the two principals; every audit chain, every electronic-signature workflow, and every Beyond-Use Date (BUD) computation that reaches production is reviewed and verified by a principal before release.
Continuity. Each engagement letter provides for source-code escrow or repository transfer, a documentation standard sufficient for a successor engineer to maintain the system, and export of the client's data in open formats on termination. A two-principal practice carries key-person risk; the engagement letter is written so that the client's system of record survives it.
The Regaldi ERP implements Part 11 natively, from the first commit. Audit records are tamper-evident and cryptographically bound to user identity; session lifetime is constrained to fifteen minutes; every electronic signature employs two distinct identification components in accordance with 21 CFR 11.200(a); the signing layer is designed to prevent one operator from signing as another; Part 11 §11.10(e) audit-trail completeness is verified through chain-walk validation. The conformance evidence travels with the codebase. Scaling to additional sites or jurisdictions does not require re-architecting that evidence, while each facility still executes its own validation and qualification.
Every engagement opens with a written process and compliance audit. The audit names every gap against the operating SOPs and the applicable USP chapters, every Part 11 control absent or under-implemented in the existing estate, and every documented deviation that has not yet been closed. The deliverable is an architecture and remediation plan, agreed in writing with the client before code is written.
Simplification of process precedes automation; automation precedes machine-learning support; machine-learning support is added only where simplification and automation alone are insufficient to the regulatory standard. Selective application of machine-learning at specific control points (rather than at every workflow surface) keeps the signature discipline intact and the validation surface manageable.
At every step of every engagement, the second-verifier signature, the PIC release authority, and the chain of custody remain with the licensed human operator. Regaldi-built software supports the checking pharmacist; it does not replace the signature.
The practice stands behind two systems of record. Regaldi Ledger, the sterile-production ERP engineered to 21 CFR Part 11 and GAMP 5, and Regaldi Herald, the pharmacy CRM in production at a seventeen-year compounding practice. The compliance architecture both are built on is documented, provision by provision, in the compliance ledger.
Regaldi accepts a limited number of engagements per quarter. To request a written practice memo, write to the principal at office@regaldi.ai. The memo describes scope of work, the applicable regulatory framework, prospective deliverables, and timeline. Initial correspondence is by letter; a first call is scheduled after the memo has been exchanged and reviewed by both sides.