Remi
The legal side of Remi: what the lawyer told me before I sold a single pill
On October 13 I had 21 minutes with a lawyer to go over everything Remi needs legally. Remi was two weeks old. Here's what came out of that meeting and what comes next.
- Treating only diabetes, high blood pressure, and weight makes the legal path much easier: these aren't among the most controlled drugs.
- GLP-1 is the hardest part: I'll only work with labs that already have a sanitary registration.
- Because the doctors are Remi employees and not third parties, we do need to look at insurance, both for medical care and for personal data.
- The pharmacy will be our own and have no counter, but it still needs a COFEPRIS operating notice and a licensed health officer.
Remi is a monthly membership for people with diabetes, high blood pressure, or weight problems. It includes an AI companion on WhatsApp, in-house doctors and nurses, Remi-branded medications delivered to your door, and connected devices: glucose meter, blood pressure monitor, and scale.
In software I almost never start with the legal side. Here there's no choice. If you prescribe, store health data, and ship medications to people's homes, the law defines what you can sell and how.
On Tuesday, October 13, I sat down with a lawyer for 21 minutes. I showed him the whole platform and asked him to tell me what was missing. Remi was two weeks old.
Three conditions, nothing else
The first question was which drugs we'd prescribe. Metformin, losartan, GLP-1, and insulin.
I told him Remi only treats diabetes, high blood pressure, and weight. If someone comes in with a sore throat, we don't prescribe anything: we refer them to another doctor.
His answer: that makes the regulatory path much easier. These drugs aren't among the most controlled. The most controlled are narcotics and psychotropics, which require special prescriptions the pharmacy has to validate. Metformin and losartan behave more like behind-the-counter drugs: you get prescribed once and you can buy them again. What you need is a prescription that meets all the requirements. The problems with e-prescriptions are with other kinds of drugs.
Limiting Remi to three conditions was a product decision. I didn't know it was also the most important legal decision.
GLP-1 is the hard part
Everything we sell is white-label: products that already exist, with their certification, and our design. The boxes and bottles say Remi.
With metformin and losartan it's simple. With GLP-1 it isn't. There are COFEPRIS issues I still have to sort out.
The rule I came away with: I'll only work with labs that already have the product's sanitary registration. And before signing, I need to confirm with the lawyer whether the box can carry the Remi brand under the lab's registration.
Devices work the same way. They're Chinese models that already have their certifications. We don't change anything on the device except the logo. What does change is the software: the manufacturer gives us access to connect it to our app. There's no deal with any manufacturer yet; we're negotiating.
The doctors are mine, and that changes the insurance
This was an important difference. For low-risk telemedicine platforms that just connect patients with doctors, the lawyer thinks medical liability insurance isn't worth it, because each doctor has their own.
Remi isn't a middleman. The doctors and nurses will be hired by Remi, in a 24/7 call center, wearing Remi coats. The patient knows Remi is the one treating them.
In that case we do need to look at insurance. There are two risks: providing health services and storing personal data. The lawyer will put together a risk checklist with how to mitigate each one, including insurance.
Recording consultations with AI
Every consultation is recorded and an AI takes the notes. That requires notice and patient consent before starting.
I already had templates for four documents: privacy notice, terms and conditions, AI use notice, and telemedicine consent. They're templates; they're missing a lot. The lawyer will review and complete them.
Data is encrypted and hosted in Mexico. For now Remi only operates in Mexico.
The brand and the software
He asked whether the trademark was registered. I said it was in process with IMPI. He said that's critical, including to protect the domain. I have to finish it.
He also suggested protecting the software and the AI with a copyright registration at INDAUTOR. That wasn't in my plan.
The counterless pharmacy
After the meeting I decided the pharmacy will be our own: a dark pharmacy, no public counter, just a warehouse and shipping.
Even without a counter, it needs an operating notice with COFEPRIS and a licensed health officer. The notice has to be filed at least 30 days before starting operations. And GLP-1 needs refrigeration at 2 to 8 °C with temperature logging.
The other option I'll compare is using the warehouse of a logistics operator that already has its notice.
What you can't advertise
Prescription drugs like GLP-1 can only be advertised to health professionals. That shapes the campaign: we sell the public Remi's medical service, not the medicine. Influencers can't talk about GLP-1 or any prescription drug. And the campaign needs COFEPRIS advertising permits.
What's next
The lawyer already sent his proposal. The to-dos:
- Pick the type of company, for tax and regulatory reasons, and incorporate.
- Review and complete the four legal documents.
- The risk checklist, including insurance.
- Finish the trademark registration with IMPI.
- Confirm which GLP-1 labs already have a sanitary registration.
- Decide where the warehouse goes.
Suppliers, devices, and permits all depend on this. That's why it comes first.
If you're building something in health in Mexico, decide early what you won't treat. That saved me more legal trouble than any document.
Learn how to build a company by watching me build mine.
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