Pharma Regulatory Matters

At Leyva, Montenegro, Trigueros Abogados, in order to answer our customers’ needs in the pharmaceutical and chemical industry, as well as other areas related to final consumer goods, we keep our clients updated on the regulations that must be followed for obtaining permits for the sale and / or manufacture of drugs, food, beverages, medical devices, and all products subject to sanitary regulation through the Comisión Federal para la Protección Contra Riesgos Sanitarios (COFEPRIS).

Our engineers and attorneys, highly specialized in this area, have represented several national and international clients in regulatory matters in Mexico.

Our services include:

• Prosecution and annulment of sanitary registrations.
• In case of products that require a sanitary registration for sale in Mexico, we obtain the corresponding authorization for their importation and / or distribution.
• Obtainment of permits and advertising notices.
• Health consultancy, including from legal and technical requirements to negotiation with regulatory authorities.
• Advice on the labeling and packaging of health-related products in accordance with the NOMs.