Regulatory

Calderón & de la Sierra offers support to customers who require regulatory approvals seeking to place their products or services in the market in Mexico.

Many business and industrial sectors are facing a rising wave of regulation and more aggressive authorities. Clients, in sectors such as the pharmaceutical, food and beverage, cosmetics, telecommunications, consumer products and energy industries, are increasingly turning to our lawyers for the purpose of providing them with advice. Our team offers experience and creative thinking in areas such as health, safety, competition, data protection, licensing, among others.

We offer tactical advice and effective representation in matters related to licensing and protection before various federal, state and municipal agencies. We have extensive experience representing clients in regulatory investigations and procedures before administrative entities.

Our understanding of the complexities at all levels of government and regulatory frameworks is enhanced by the knowledge of the specific sectors of the industry that those entities regulate, allowing us to provide advice on the impact of projects, their change policies, The potential impact of such changes and planning on legislative changes in the matter well in advance of their implementation.

Our regulatory team has significant and recognized experience in obtaining sanitary records of pharmaceutical products before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), as well as with products related to alcoholic beverages, tobacco, fertilizers, pesticides, Veterinary use and cleaning products.

In addition to requesting regulatory authorizations for products, our Firm also initiates legal proceedings against COFEPRIS when a health registration has been granted to a third party to market a product, although it is protected by a patent published in the Industrial Property Gazette.

Although our work related to legislative advice and our Regulatory Area are different from each other, they are closely linked. Our regulatory work strives to help our clients understand and plan actions derived from regulatory changes in our country, in order to advance their business objectives.

Our legislative practice involves working with legislators in Congress and at all levels of the Executive Branch to ensure that the interests of our clients are protected.