Consulting

Access to Mexico's public health market.

We prepare the economic evidence, the value dossier and the institutional route so that medicines and devices enter the National Compendium of Health Supplies (CNIS) and public-sector procurement.

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The framework we work with
NOFCCNIS — Operating rules of the Commission of the National Compendium of Health Supplies
GCEEE — Guideline for conducting economic evaluation studies
GEI — Guideline for the assessment of health supplies
GTIETS Manual — IMSS Institutional Working Group for Health Technology Assessment
Supply Regulation — ISSSTE Health Supplies Procurement Regulation
COFEPRIS — Sanitary registration, variations and vigilance
Consolidated procurement — Reference prices and public-sector tenders
Why Mexico

A market worth understanding well before you enter.

For an innovative health supplies company, Mexico combines scale, a public system with multiple institutions, and explicit assessment rules.

130 M+ Scale Over 130 million people and one of Latin America's two largest economies, with an ageing population and a growing burden of chronic disease.
Multiple A fragmented system A fragmented health system with multiple institutions (IMSS, ISSSTE, IMSS-Bienestar, SEDENA, SEMAR, PEMEX), each with its own regulations, processes and access timelines.
1 key Explicit rules A code in the National Compendium of Health Supplies opens the whole public sector, and the General Health Council publishes the guidelines it assesses with: those who meet them compete on equal terms.

Sources: CONAPO, population projections 2025 · General Health Council, NOFCCNIS (DOF 2024, 2025 reform), GCEEE and GEI (2023) · COFEPRIS, equivalence agreements with reference regulatory agencies.

Market access

Everything a dossier needs to be assessed and approved.

Health economics studies Cost-effectiveness, cost-utility, cost-benefit and cost-minimization analyses; budget impact analysis, cost calculators and health impact assessments, under the GCEEE.
Value dossiers Design and preparation of dossiers aligned with the guidelines of the General Health Council and of public healthcare providers.
Medical need letter Support in obtaining the official letter of medical need (article 23, section V, of the CCNIS rules).
CNIS dossiers and deficiency letters Assembly of inclusion or modification applications and responses to deficiency letters from the Technical Secretariat, including multi-criteria analysis.
Access monitoring Tracking and analysis of the administrative processes of public market access until the code turns into a purchase.
Value strategy and pricing An integrated value proposition from the public payer's perspective and a pricing strategy against consolidated-procurement reference prices and Compendium comparators.
Risk-sharing agreements Design of financial and outcomes-based risk-sharing agreements adapted to Mexico's public procurement framework.
COFEPRIS regulatory affairs Medical device sanitary registration, variations, instructions for use, importation and technovigilance.
Market research

The evidence and the voices a launch needs.

We generate and communicate evidence with the medical community and decision-makers.

Advisory boards and Delphi panels Systematic reviews and meta-analyses Coordination of academic sessions Burden-of-disease studies Key opinion leader and speaker engagement Outcomes research studies Medical writing for research Medical communication materials
Who we serve

Teams that need the value messages of their innovation to be understood by any institution in Mexico.

Pharmaceutical companies Market access, HEOR and medical affairs teams submitting new molecules, indications or biosimilars.
Medical device manufacturers Sanitary registration, a Compendium code and a tender entry strategy.
Healthtech start-ups Regulatory and reimbursement route from product design, not after launch.
International companies without a local presence Registration holding, importation and distribution with Lybb's operational backing.

Do you have a submission in the next twelve months?

In one call we tell you what evidence is missing and how long it takes to gather it.

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