Viability Report
Preventive ingredient analysis before you invest in production. We determine if your product can legally enter Mexico and flag any prohibited or restricted substances.
Mexico regulatory compliance
COFEPRIS approval on the first try.
12+ Growve brands launched in Mexico with 100% first-pass COFEPRIS approvals. We coordinate the lab work, the regulatory file, and the authority review — you ship into Mexico without surprises at customs.
100%
First-pass approval (Growve portfolio)
12+
Growve brands launched in Mexico
5×
Faster label review vs traditional firms
~25/mo
Labels reviewed for high-volume clients
Proof point
Growve launched 12+ wellness brands in Mexico with 100% first-pass COFEPRIS approvals.
We prepare the regulatory file. The Mexican public notary protocolizes the entity. SAT issues your RFC and the company’s e.firma. COFEPRIS issues the Aviso de Funcionamiento, the Permiso Sanitario, or the Registro Sanitario — depending on your product class.
12+Brands launched
10 wksZero to operational
100%First-pass approval rate
What requires COFEPRIS approval?
Any product that contacts the human body must comply with Mexico’s health authority. Timelines and permit class depend on the category.
| Product category | Regulation level | Typical timeline | Key permit |
|---|---|---|---|
| Cosmetics | Low | 3 – 15 days | Aviso de Funcionamiento |
| Food & beverages | Medium | 1 – 3 months | Aviso + import permit |
| Dietary supplements | High | 3 – 6 months | Aviso + Permiso Sanitario |
| Supplements (Registro) | Very high | 6 – 12 months | Registro Sanitario |
| Medical devices (Class I–III) | Very high | 6 – 18 months | Registro Sanitario |
| Pharmaceuticals | Maximum | 12 – 24 months | Registro Sanitario |
From viability report to market launch.
A complete regulatory function for foreign brands entering Mexico — built in-house. No outsourced consultants. No translation games.
Aviso de Funcionamiento
Government registration declaring your company will store or sell health products. Required before any regulated product can be imported. We handle the full filing.
Registro Sanitario
The “sales permit” for complex products: medications, medical devices, and certain supplements. Full dossier preparation and submission to COFEPRIS.
Permiso Sanitario de Importación
Per-shipment import permit for regulated products. Required each time supplements, food, or health products cross the border. Valid for 30 days per permit.
Responsable Sanitario
We link a licensed health professional (with cédula profesional) to your entity to supervise operations. Legally required for all companies handling health products.
Label review & NOM oversticker
Design of compliant oversticker labels with all COFEPRIS-required warnings, nutritional tables, and ingredient lists. Our in-house team reviews labels 5× faster than traditional regulatory firms — averaging ~25 labels per month for high-volume clients.
Aviso de Publicidad
Marketing compliance permit for advertising health products. Required before running any ad campaigns, influencer partnerships, or social media promotions for regulated products.
NOM certifications
Compliance with mandatory Mexican standards for health products: NOM-050 (commercial labeling), NOM-141 (cosmetics), NOM-051 (food & beverage labeling with front-of-pack warnings).
SENASICA compliance
Sanitary permits from Mexico’s animal and plant health authority. Required for animal-origin products, plant-based supplements, and agricultural goods.
Catch problems before they cost you.
Two things separate Tally’s COFEPRIS workflow from a broker model.
5× faster
In-house chemical-legal team
Unlike brokers who outsource regulatory work, Tally runs an integrated team of regulatory specialists with chemistry and legal backgrounds. Label reviews, ingredient analysis, and COFEPRIS submissions stay in-house — no middlemen, no translation delays.
Week 1 catch
The Viability Report
Before you invest in Mexican labeling, production runs, or import logistics, we analyze every ingredient against COFEPRIS regulations. If your product contains a prohibited substance, we catch it in week one — not after your container is stuck at customs. This saves clients thousands in wasted production and shipping costs.
From file to permit issued.
Tally prepares the file. COFEPRIS reviews and issues. We coordinate the lab work, the Responsable Sanitario, and the submission — you ship into Mexico without surprises.
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Viability ReportWeek 1
We analyze every ingredient against COFEPRIS regulations. Prohibited or restricted substances surface immediately — before you commit to production or labeling spend.
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Responsable Sanitario assignedWeek 1–2
We link a licensed Responsable Sanitario (with cédula profesional) to your entity. Legally required for any company handling health products in Mexico.
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Regulatory dossier preparedWeeks 2–4
Aviso de Funcionamiento, Permiso Sanitario, or Registro Sanitario dossier — depending on your product class. We compile lab tests, COAs, technical sheets, NOM labels.
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COFEPRIS submission and follow-upWeeks 4–16
We submit to COFEPRIS and manage every requirement or prevention. First-pass approval is the goal — 100% rate for the Growve portfolio across 12+ brands.
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Permit issued and import ready
COFEPRIS issues the permit. We coordinate with your customs broker so the first shipment clears without a hold.
Boundary: Tally prepares the regulatory file and runs the submission. COFEPRIS issues the Aviso, Permiso, or Registro Sanitario. The Responsable Sanitario is a licensed health professional registered on your entity — we link, you employ.
Common COFEPRIS questions.
Any product that contacts the human body: dietary supplements, cosmetics, food products, beverages, medical devices, and pharmaceuticals. The level of regulation varies — cosmetics can be cleared in days, while medical devices may take over a year.
Cosmetics: 3–15 days. Food supplements: 3–6 months. Products requiring Registro Sanitario: 6–18 months. We begin all other setup steps (entity, banking, imports) in parallel so you’re ready to sell the moment your permit arrives.
A preventive ingredient analysis we conduct before you invest in production. It determines whether your product can legally be sold in Mexico and flags any prohibited or restricted substances. This is what gives Tally the 100% first-pass approval rate — we catch problems in week one, not week ten.
A licensed health professional legally required to supervise operations involving health products in Mexico. Tally links qualified professionals to your entity on a monthly retainer basis.
Yes. NOM labels are mandatory for all consumer products entering Mexico. NOM-050 covers general commercial information. NOM-141 covers cosmetics. COFEPRIS permits and NOM labels are separate requirements but both mandatory.
COFEPRIS support included in every plan.
Viability reports, label reviews, and regulatory guidance are included. Registro Sanitario dossiers are quoted separately per product class.
Ready to clear COFEPRIS the first time?
Start your application. We’ll run a Viability Report on your products and confirm timelines in 48 hours.
Start your application