We provide regulatory counsel and litigation relating to manufacturing, import, distribution, marketing, labeling and advertising of pharmaceutical products, medical devices, pesticides, fertilizers, cosmetics and household cleaning products, veterinary products, seeds, foods, beverages, alcohol and tobacco.
Basham has a multidisciplinary practice team which consists of lawyers, chemists, and biologists, who ensure a comprehensive vision of client cases and inquiries from a technical, regulatory, and legal point of view, through meaningful collaboration. We also offer industry-specific specialized litigation services at an administrative and constitutional level.
Our legal services include:
- Processing, monitoring and obtaining of permits, licenses and marketing authorizations before the Federal Commission for the Protection Against Sanitary Risks ("COFEPRIS") and other relevant sanitary authorities and agencies.
- Structuring and execution of complex regulatory projects derived from corporate operations, such as mergers and acquisitions, both local and international.
- Registration of medicines and therapeutic devices.
- Registration of pesticides, fertilizers, and growth catalysts.
- Drafting and negotiation distribution agreements for the pharmaceutical industries.
- Obtaining of advertisement permits in regulated industries.
- Product recall procedures and notices, as well as product liability consulting.
- Management and obtaining authorizations to import and export regulated consumer products, medicines, and therapeutic devices.
- Negotiations with federal and state health and regulatory authorities.
- Advice, analysis, and implementation of Official Mexican Standards.
- Verification of packaging and labelling of regulated products according to applicable regulations.
- Legal support for the inclusion of medicines in the national formulary of the health sector.
- Obtaining health registration for biocides used in industrial processes for BASF in Mexico.
- Strategy and legal defense for the obtaining of an orphan drug designation of an orphan drug for Alexion Pharmaceuticals in México.
- Drafted and negotiated distribution contracts for pharmaceutical products imported to Mexico by a US company.
- Voluntary recall procedure a of cosmetic products for an American company.
- Advised and executed the transmission of health registrations of class II medical devices for a Dutch company.