REGULATORY MATTERS
What is product certification?
At ADNG Regulatorio, we provide comprehensive support in obtaining your federal documents issued by the authorities.
We are the link with the relevant authorities, managing procedures valid at the federal and state levels, both in Mexicoas inthe United States (FDA).
Procedures and formalities in Mexico
We have a specialized regulatory team that understands the technical complexity of each sector.
Our priority is to provide you with strategic, clear, and reliable solutions so that you can meet your deadlines without delays or uncertainty.
WE CARRY OUT PROCEDURES BEFORE THE SAT, SAGARPA, SEMARNAT, COFEPRIS, COESPRIS, SECRETARIA DE ECONOMIA, SECRETARIA DE SALUD, SEDENA, PROFEPA, PROTECCION CIVIL, SECRETARIA DE TRABAJO Y PRESÉS SOCIAL
Advantages
Experience in national procedures and FDA.
Complete technical and documentary advice.
Personalized follow-up.
Effective communication with authorities.
Why choose us?
What does the FDA (21 CFR) regulate?
Title 21 of the Code of Federal Regulations (21 CFR) establishes the technical and quality requirements for food, cosmetics, pharmaceuticals and medical devices intended for the US market.
Its objective is to guarantee safety, traceability and regulatory compliance in every product.
Ensure your products comply with FDA guidelines for entry and sale in the United States.
We guide you through the entire regulatory process to AVOID penalties, delays and product returns.
Main challenges we help solve:
Incorrect or incomplete submissions that delay approval.
Lack of knowledge of the technical and labeling requirements demanded by the FDA.
Risks of fines or restrictions for non-compliance.
Lack of specialized advice on binational regulations.
How we support you:
Preparation and review of files for smooth approvals.
Technical advice on labeling and documentation in accordance with FDA.
Monitoring compliance to prevent observations and penalties.
Comprehensive support until final product validation.
With ADNG Regulatorio, you have a technical ally that transforms international procedures into safe, clear, and legally compliant processes.