Mexico’s Life Sciences & Healthcare accounts for 12% of gross domestic product. Companies operating in the sector face significant challenges, with a complex regulatory landscape, strong influence from the government both as a regulator and as the biggest buyer, and intense competition from local and international stakeholders.
CMS Woodhouse Lorente Ludlow lawyers understand the complexity of an interdisciplinary business, have deep understanding of the law and are very aware of the scientific and commercial aspects related to your business. This gives us the ability to design and implement regulatory and government affairs strategies to achieve clients’ business goals.
The team has experience advising clients through the entire productive process of regulated products, manufacturing, warehousing, transportation, distribution, imports and exports, retail and advertisements. We are experts in advising companies with new businesses and products, drafting regulatory strategies, performing regulatory compliance audits, advising on good manufacturing practices and certifications, premarket approval of products and services, health licences, cross-border classification of products, and advice on approval of labelling and marketing of regulated products and services.
We also represent clients before the health authorities in regulatory enforcement administrative procedures and design crisis management strategies in cases of voluntary recall of products, seizure of products by the authorities and closure of facilities.