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About

Bridging Regulatory Compliance

Expert Support for FDA Regulations and ISO Standards

After years of experience in FDA-regulated industries in Mexico, we identified the growing need among Mexican and Latin American companies exporting or aiming to export their products to the U.S. market. These companies often need to comply with applicable regulations, which can remain a challenging area as daily operations make it difficult to stay updated with the expectations of the U.S. regulatory authorities. We also support companies through consulting and advisory services in the implementation or continuous improvement according to ISO 9001 and ISO 15378 standards.

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Mission

To provide comprehensive and personalized solutions to help Mexican and Latin American FDA-regulated companies meet the highest standards of quality and safety. Through our expertise in international regulations, we facilitate navigation through regulatory requirements that protect public health and promote our clients' commercial success.

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Vision

To be the leading consulting firm for FDA-regulated exporting companies. We aspire to be the strategic partner for Mexican companies, fostering competitiveness in a global environment, ensuring our clients operate under the strictest standards to successfully and confidently enter and operate in the U.S. market.

Business Decisions

Values

At FDA Consulting, we are committed to our clients by prioritizing their needs and providing personalized solutions. We value integrity by acting with honesty, ethics, and excellence, always seeking continuous improvement in our services. Additionally, we promote teamwork with our clients to achieve optimal results.

Our Philosophy

Customer-Centric and Knowledge-Driven Approach

Customer-oriented, focused on expanding knowledge so that companies do not navigate unknown waters in complying with the regulations required by the United States for their commercial success in that country.

Global Conference Call
Dedicated Customer Support
Business Protection 1
Regulatory Compliance Expertise