Business architecture
We map the operation and rebuild how it runs. Roles, procedures, the order things happen in. Decades of building businesses and running regulated pharmacy, applied to yours.
Regaldi rebuilds how a regulated business runs: the software, the workflow, the controls, and the demand that fills the floor. Then we put an AI assistant at every operator's shoulder. Over one production engagement, order processing at the operator workstation ran twenty times faster and gross revenue doubled.
This is a seventeen-year compounding pharmacy. Before Regaldi, the work was done by hand and growth was capped by how fast people could type. Toggle the panel to see what changed.
Putting AI into a business is easy to say. Doing it safely is the work. We do all of it: the processes, the systems of record, the compliance controls, the assistant at every desk, and the demand that fills the floor.
We map the operation and rebuild how it runs. Roles, procedures, the order things happen in. Decades of building businesses and running regulated pharmacy, applied to yours.
The governing rule sits at the point of action, not in a binder. A batch cannot advance until it is satisfied of record; a skipped step is not an available action. The inspection becomes a day you are ready for.
We put an AI assistant beside each operator. It listens, drafts, reconciles, and warns, so the person moves faster and misses nothing. It multiplies the operator. It never signs for them.
Bespoke pharmacy ERP and CRM, built on one engineered core and configured to the way you already work rather than imposed as a template. The ERP implements 21 CFR Part 11 natively from the first commit; the CRM preserves the pharmacist's signature discipline at every release. The core is built once; each facility is provisioned on top of it.
We position the business, build the funnel, and bring the prescribers. A direct-outreach list reaching more than one hundred thousand physicians and clinics feeds the floor; that figure is the reach of the list, not a count of customers.
If anything drifts out of spec, you know at once. The operation stays under control, and the record shows the drift before a person has to go looking for it.
Regaldi does not staff offshore teams or deliver through subcontractors of subcontractors. What scales is the platform: a core built once, with the CRM proven in daily production and the ERP awaiting its first facility's activation. What stays senior is the judgment. Two principals stand behind the work, by name. Veronica Taran is a Florida-licensed pharmacist with more than three decades in regulated compounding operations. Adam Sarman holds an MBA and an engineering degree and has spent two decades building and running operating businesses. The engineering is done in-house and verified by the principals before it ships. The platform carries the volume; the licensed professional keeps the judgment, the signature, and the credit.
Whether you run a regulated operation today or are standing one up, the engagement opens the same way, with a written audit, and ends the same way, with the licensed professional holding the signature.
We audit the existing software estate against your SOPs and Board of Pharmacy expectations, then remediate and rebuild, preserving the way the operation already works.
We deliver the systems of record a 503B outsourcing facility needs to operate, native to 21 CFR Part 11 from the first commit, built for the inspection that opens the doors.
We take the chaos and the fear out of regulated business, and we give every person who works in one an assistant that never sleeps. So the operation runs calmer and safer, produces more, and the licensed professional keeps the judgment, the signature, and the credit.
We begin where the rules are hardest, in sterile compounding and the 503B outsourcing facility, because a system built to pass an FDA inspection there is built for any operation a regulator can walk into.
Read the architecture: the 21 CFR Part 11 compliance ledger the assist layer, under signature
Whether you run a pharmacy today or are standing one up, Regaldi will audit the operation, design the rebuild, and put the assistant beside your people. To request a written practice memo, write to the principal at office@regaldi.ai.