What steps should a Mexican pharmaceutical company take to obtain FDA clearance for a drug intended for distribution in the United States?

Question

We want to understand the regulatory pathway, documentation, and timelines. The company operates in Mexico and seeks guidance on compliance with FDA requirements, including facility registration, labeling, and good manufacturing practices. Specifically, we need clarity on whether clinical studies are required and how to coordinate with US distributors.

Recovery Legal Mexico · Accepted Answer

Il s’agit d’un sujet très intéressant qui nécessite l’expertise de professionnels au Mexique et aux États-Unis pour répondre correctement à votre question. Veuillez nous contacter à [email protected] afin de planifier une réunion pour en discuter.

Salutations,

César Rendón

Avocat

Salutations,

César Rendón

Avocat

What steps should a Mexican pharmaceutical company take to obtain FDA clearance for a drug intended for distribution in the United States?

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