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Navigate FDA Regulations with Confidence

FDA Consulting for Latin American Firms Entering

the U.S.

  • Responses to 483
  • Responses to Warning Letters
  • Responses to Import Alerts
  • cGMP (Current Good Manufacturing Practice)
  • Quality System
Our Services

Comprehensive Solutions for
FDA Regulatory Compliance

Bookkeeping

GAP Analysis

Assess your compliance status and identify areas for improvement.

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Responses to 483

Expert guidance in addressing FDA Form 483 observations.

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Retirement Planning

Responses to Warning Letters

Comprehensive support to respond effectively to Warning Letters.

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Business Protection

Removal of Import Alerts

Strategic plans to lift Import Alerts and resume exports.

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Office Buildings

cGMP Compliance

Ensure your manufacturing practices meet FDA standards.

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Financial Graph

Quality Management Systems

Implement and maintain ISO 9001 and ISO 15378 standards.

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us fda consulting who we are
Who We Are

Your Trusted Partner in Navigating FDA Regulations

With years of experience in FDA-regulated industries across Mexico and Latin America, US FDA Consulting is dedicated to helping companies successfully navigate the complex landscape of U.S. regulatory compliance. Whether you’re looking to export your products or enhance your quality systems, our expert team provides tailored solutions to meet your unique needs.

Time Efficiency

15

Years of Expertise
11

137

Successful Clients

Ready to Elevate Your Compliance?

Take the next step towards ensuring your regulatory compliance and market success. Partner with our expert team today.

US FDA Consulting
Why Choose Us

Excellence in FDA Regulatory Compliance

At US FDA Consulting, we are dedicated to providing comprehensive solutions that ensure regulatory compliance and drive commercial success for our clients. Our key strengths include:

  • Deep FDA Expertise
  • Proven Success Record
  • Tailored Strategic Solutions
fda consulting Responses to 483 us
fda consulting in usa cGMP
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US FDA Consulting
US FDA Consulting
What Our Clients Say

Hear from Our Satisfied Clients

young latin business woman working outside of offi 2023 11 27 05 33 53 utc

"US FDA Consulting provided outstanding support during our FDA audit preparation, ensuring we met all regulatory requirements with confidence"

María González

Quality Manager at BioMed Solutions
latin guy posing in profile with a wall of blue an 2023 11 27 05 33 37 utc

"US FDA Consulting transformed our compliance, enabling seamless entry into the U.S. market. Their expertise and personalized approach were key to our success"

Juan Pérez

CEO of PharmaLat