Tania Martinez, Demos Global Group: "The United States is not a country for taking risks; success depends on strict regulatory compliance."

 

Tania Martínez, President of Demos Global Group, explains in Madrid the keys to exporting to Estados Unidos Today. In light of the new regulations of the FDA y AmazonTechnical preparation is the only way to avoid commercial failure in the North American market.

 

About Demos Global GroupThe regulatory bridge with North America

 

Demos Global Group It is a leading international consultancy that facilitates access to global markets, specializing in regulatory compliance. Estados UnidosWith over 30 years of experience and 18 years of direct presence in EspañaThe firm has established itself as a key strategic partner for sectors such as food, cosmetics, and medical devices. Its differentiating value lies in being one of the few certification bodies officially accredited by the FDA (Food and Drug Administration) under the program FISMA from third parties.

 

As President and CEO of Demos Global Group, Tania Martínez She leads compliance strategy for companies seeking to consolidate their position in the US market. She is an attorney with professional experience in both España as in Estados UnidosMartínez provides a vision bicultural It is the only organization that enables Spanish exporters to understand and adapt to the complex US legal system. Its work focuses on education, auditing, and implementing critical regulations to ensure safe market access without technical risks.

 

Interview: 25 years of evolution in foreign trade

 

En Empresa Exterior We are celebrating our 25th Anniversary by taking stock of this quarter of a century. From your experience, how has the professionalization of Spanish companies evolved in response to the regulatory requirements for exporting to EE. UU.?

 

Tania MartínezDuring this time there has been everything, but it is a reality that we have experienced directly: there is great development on the part of serious Spanish companies in their exports to Estados Unidos. When i talk about reputable companyI'm referring to those who have a genuine commitment to meeting the necessary standards and certifications to remain competitive in the market. On the other hand, there is a minority that tries to "venture" into the market. We must be clear: Estados Unidos It offers every possible benefit to trade, but demands a strict path of regulatory compliance. Failure to do so will result in complete failure.

 

With the new demands of platforms like Amazon and the regulatory framework of the FDAWhat is the main role of Demos Global Group today?

 

TMWe are not a conventional consulting firm; we are part of the North American regulatory structure. Demos Global Group is the only entity based on España officially authorized by the FDA to certify under the law FSMA. Regarding AmazonToday, the platform requires mandatory certification. GMP (Good Manufacturing Practices) certificate issued by an authorized entity to sell products as dietary supplements. We operate under a local cost structure in Españabut providing a direct service within the US federal system.

 

What are the biggest regulatory challenges you see for Spanish companies in the medium term?

 

TMThe challenge must be divided into two areas. The first is traditional: raising awareness that the North American legal structure is not the same as the European one. While here the system is more static and based on codes, there it is a system jurisprudential where a judge has the final say. The second challenge is situational; we find ourselves under an administration in Estados Unidos It is extremely demanding and has pushed existing laws to their limits. Anyone who doesn't understand this structure is bound to crash and burn.

 

What consulting solutions are you reinforcing to help SMEs be competitive today?

 

TMWe have been in the Spanish market for 34 years. Our work is based on the principle that information and education are fundamental; without them, it is impossible to operate. Tools such as Google o ChatGPT They are spectacular, but they don't replace customization based on the product profile and manufacturing process. We help implement, audit, and, if the parameters are met, we can certify. We are constantly present, giving free conferences, such as the one we will be holding on May 19th with the Cámara de Madridto keep the Spanish company informed.

 

As a final thought, what fundamental advice would you give to a Spanish executive who is considering making the leap to the North American market today?

 

TMThe first piece of advice is get prepared. Estados Unidos It has a high regulatory risk. To play in the Major League Baseball In sales, you need the necessary resources and structure. Nothing is free, not even a glass of water. The key is to work with someone who can provide effective and productive support, avoiding the typical pitfalls of those trying to "guess" the path. Preparation and information are the most valuable assets.

 

Key data from Demos Global Group and market EE. UU.

 

Concept	Information Details
Presence in Spain	34 years of local experience
Regulatory Experience	Over 30 years in regulations EE. UU.
Critical Accreditation	Officially certifying entity of the FDA
Next Event	Conference in Cámara de Madrid (May 19)
Key Sectors	Food, Cosmetics, Medical Devices and Cannabis
Global Headquarters	Miami, Madrid y Milán

 

Key points and frequently asked questions about exporting to EE. UU.

Why is GMP certification mandatory in Amazon?

To sell dietary supplements, Amazon It requires these certifications from authorized entities to guarantee consumer safety and comply with federal government quality standards.

What differentiates the legal system from EE. UU. of the European?

The American system is jurisprudential (Common Law), where judicial interpretations and congressional regulations create a dynamic framework, unlike the more static code system of Europa.

What are the risks of not having a resident agent in USA?

Without adequate legal and technical representation before the FDACompanies face merchandise detentions at customs, economic sanctions, and the permanent blocking of their exports.