Capabilities

Everything you need to enter and sell in Mexico.

One accountable team — from the first market study to registration, authorized distribution, and beyond.

01

Market study & market entry

We size the opportunity and design the compliant route to market for the public and private sectors — before you commit resources.

Market & feasibility study

Demand, competition, pricing, and reimbursement landscape.

Go-to-market strategy

Public vs. private sequencing, channels, and positioning.

Regulatory route mapping

The fastest compliant path to registration and sale.

Entry model

Direct, partner, or distributor structure for your product.

02

COFEPRIS registration & regulatory affairs

End-to-end sanitary registration for every pharmaceutical category, managed to milestones.

All product categories

Generics, biologics, biosimilars, biotech, vaccines, and medical devices.

Dossier & submission

Classification, gap analysis, and submission strategy.

Legal representation

Local holder / legal manufacturer for companies without a Mexican entity.

GMP & compliance

Documentation alignment and inspection readiness with certified partners.

03

Authorized distribution

We can act as your authorized distributor and legal representative in Mexico — turning a registration into sales.

Authorized distributor

Local commercialization of your products, compliantly.

Public & private channels

Distributors, hospitals, pharmacies, and institutions.

Logistics & supply

Import, storage, and delivery coordination.

Pricing & positioning

Against reference pricing and procurement benchmarks.

04

Public tenders & institutional access

Strategy and participation in federal and institutional procurement — where much of Mexico's pharmaceutical volume moves.

Tender strategy

Eligibility, positioning, and participation in public processes.

Institutional access

Engagement with public health and procurement bodies.

Compliance & documentation

Meeting the requirements of federal purchasing.

Government relations

Structured, compliant institutional dialogue.

05

Import & international trade

Cross-border support for manufacturers sourcing, importing, or scaling in Mexico.

Sourcing & imports

Supplier qualification and lawful import structuring.

Documentation workflows

Regulatory and customs documentation coordination.

Trade compliance

Alignment with obligations across the import chain.

Commercial positioning

Market framing for entering or scaling in Mexico.

06

Technology transfer & local manufacturing

Development of advanced manufacturing and API localization in Mexico with GMP-certified partners.

View the flagship project

Feasibility framing

Technical, regulatory, and commercial feasibility for localization.

Partner engagement

Structured collaboration with GMP-certified technology holders.

Fill-finish & API

Pathways toward local production across the value chain.

Institutional alignment

Positioning for economic, health, and investment stakeholders.

How we work

A structured engagement, from question to capability.

Phase 01

Assess

Objectives, constraints, regulatory exposure, and the fastest compliant route.

Phase 02

Structure

The strategy, stakeholders, documentation, and commercial or partnership model.

Phase 03

Execute

Registrations, imports, tenders, and institutional dialogue — managed to milestones.

Phase 04

Scale

Market presence, partnerships, and — where relevant — local production capability.

Contact

Tell us what you're trying to achieve in Mexico.

We'll tell you the fastest compliant path — and what it takes to execute it.