We advise innovative and generic drug companies, biotech firms, manufacturers, importers and distributors across the full product lifecycle: development, authorization, manufacturing, commercialization and post-marketing surveillance. 

Mexico’s pharmaceutical framework changed substantially in 2026. The General Health Law amendment (Official Gazette, January 15, 2026) established the Federal Health System and made pharmacovigilance part of the sanitary responsible officer’s legal duties, and the April 2026 amendment to the Health Supplies Regulations reshaped the rules on new molecules, regulatory data protection and renewals. We translate these changes into regulatory, intellectual property and business strategy. 

 

Services 

• Regulatory and market-entry strategy for new molecules, generics, biologics and biosimilars. 

• Marketing authorizations, renewals and variations, including abbreviated reliance pathways based on reference regulatory authorities. 

• Regulatory data protection, patent linkage and compensation for regulatory delays, with our Intellectual Property practice. 

• Sanitary licenses, operating notices, sanitary responsible officer and import permits. 

• Good manufacturing practices and inspection readiness for COFEPRIS and foreign authorities, including the FDA. 

• Pharmacovigilance and technovigilance, and pharmacovigilance and bioequivalence agreements. 

• Clinical research: protocols, ethics committees and clinical trial agreements. 

• Advertising to healthcare professionals and the public, and HCP interaction programs. 

• Public procurement, consolidated purchasing and health-sector tenders, with our Administrative Law practice. 

• M&A, licensing, technology transfer and joint ventures, and regulatory due diligence. 

• Administrative and amparo litigation over marketing authorizations and sanitary permits. 

 

Representative experience 

• Designed and executed the Mexican market entry of a foreign pharmaceutical company: incorporation, distribution and warehousing agreements, regulatory classification and COFEPRIS filings through commercial launch. 

• Advised a global company on an FDA inspection in Mexico, which closed with no written observations and no Form 483. 

• Represented Serral in the sale to Pfizer of drug sales licenses and related intellectual property, and in a joint venture with Pfizer. 

• Represented STADA Arzneimittel AG in legal due diligence for the potential acquisition of a Mexican laboratory. 

• Acquisition of pharmaceutical assets for Representaciones del Refugio, including technology, dossier, marketing authorization, trademarks and licensing agreements. 

• Advised the Mexican Association of Pharmaceutical Laboratories (AMELAF) on negotiating the intellectual property chapter of trade agreements. 

• Legal strategy and litigation to obtain and maintain marketing authorizations for biotechnological drugs. 

Representative Cases 

• Represented the entrepreneurs of Hospital H+ Los Cabos in the initial equity capital raises and in their negotiations with the private equity fund that acquired a portion of the partnership.
• Represented Landsteiner Scientific, one of the largest and most important pharmaceutical companies in Mexico, in obtaining a financing agreement.
• Advised PROBIOMED, in 2018 filed for bankruptcy due to the various challenges faced by the company as a result of new regulations in the pharmaceutical industry, as well as new requirements made by governmental authorities.
• Represented Sterimed, in the acquisition of Especialistas en Esterilización y Envases (EEE), a world leader in the manufacture and distribution of health-related products, as part of its expansion plans in LATAM.
• Advised Grupo Farmatodo in the negotiation and structure of a joint venture and co-investment with Controladora de Farmacias, a subsidiary of Grupo Nadro, the largest distributor in Mexico of pharmaceutical and non-pharmaceutical products.
• Represented Serral Laboratorios in the negotiation and structuring of a joint venture with Pfizer.
• Represented Laboratorios Carnot in the acquisition of several industrial properties in Hidalgo, as part of Carnot’s expansion plans within Mexico for an approximate area of 80,000 square meters.
• Represented Investigación Farmacéutica S.A. de C.V. in legal actions to recover possession of a property located in the city of Cuautla, Morelos.
• Advised VitalMed Inc. in connection with its distribution chain of patent and generic drugs nationwide.
• Advised several companies in the determination of legal strategy and litigation to obtain health registrations for biotechnological drugs and maintenance of health registrations.
• Advised Mexican Association of Pharmaceutical Laboratories (AMELAF) in the negotiation of the intellectual property chapter of the following trade agreements: Trans-Pacific Partnership Agreement (TPP), North American Free Trade Agreement (NAFTA) and Free Trade Agreement between the European Union and Mexico. AMELAF is an association of pharmaceutical companies.
• Represented and advised Representaciones del Refugio, S.A. de C.V. in the acquisition of pharmaceutical assets, including the technology for the manufacture of a drug used in the treatment of influenza, dossier of the drug, marketing authorization of the drug, trademarks used to market the drug and negotiation of certain licensing and distribution agreements with the seller.
• Represented Serral, S.A. de C.V. in the sale to Pfizer Inc. of the licenses to sell certain of its drugs and transfer of intellectual property.
• Represented STADA Arzneimittel AG in the due diligence process for the possible acquisition of a Mexican laboratory. STADA is a German pharmaceutical company specialized in the production of generic and over-the-counter drugs.
• Represented Laboratorios Tornel (Mexican manufacturer of veterinary products) in an ICC arbitration concerning a failed merger and acquisition transaction.