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

This is a very interesting topic that requires experts in Mexico and the US to properly answer your question.

Regards,

César Rendón

Attoeny at Law

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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Recovery Legal Mexico

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