The practice covers regulated activities across the entire product life cycle, from clinical trials, manufacturing, importing, labeling and packaging, to advertising, marketing, and the export of products and services.  With respect to medicines, medical devices and the healthcare industry, we deliver end-to-end regulatory support before COFEPRIS and local health authorities: clinical trial protocols and the assessment and filing of marketing authorizations and notices, to post-authorization compliance and legal defense in enforcement proceedings.

The firm’s legal counseling includes advice to regulatory matters involving medicines (including OTC products, controlled substances and vaccines), medical devices, dietary supplements, infant formulas, cosmetics, pesticides and other regulated chemical substances, food and beverages, and healthcare services.  This breadth allows us to advise clients consistently across product categories that are subject to different, and frequently overlapping, regulatory requirements.

Creel, García-Cuéllar, Aiza y Enríquez has successfully represented clients in navigating the complex regulatory framework applicable to the food and beverage industry, dietary supplements and cosmetics. Our work covers ingredients and additives compliance, labeling and advertising requirements, import/export procedures, and product classification requests before COFEPRIS.

The firm focuses on getting products to market efficiently while managing regulatory and reputational risks. Chambers highlights, for example, our work advising Daesang Corporation on obtaining COFEPRIS approval to classify natural flavoring additives in Mexico.

Regulatory enforcement, including verification visits and administrative proceedings, in Mexico’s life sciences sector is intensifying. We defend clients through verification visits, enforcement actions and administrative court proceedings-protecting business continuity and preserving commercial relationships when regulatory positions come under challenge.

The Firm has also been successful in assisting clients in public procurement procedures, a critical channel in Mexico’s healthcare sector.  This combination of regulatory and contentious capability allows us to advise clients not only on how to comply, but on how to respond effectively when compliance positions are challenged.

Creel, García-Cuéllar, Aiza y Enríquez has represented major international pharmaceutical companies in establishing and expanding their Mexican operations through market entry, joint ventures, distribution optimization, and domestic and cross-border acquisitions.

Our transactional capability draws the firm’s market-leading corporate, M&A and private equity practices, integrating sector-specific regulatory knowledge with transactional execution.  Representative work includes advising on General Atlantic’s acquisition of an interest in Sanfer, one of Mexico’s largest independent pharmaceutical companies, a landmark transaction reflecting our position at the intersection of life sciences and M&A operations.