Expert FDA Regulatory Compliance Consulting
Navigate FDA Compliance
with Confidence
IUVO Consulting, LLC provides expert guidance to help medical device, drug, food, and cosmetic companies achieve and maintain FDA compliance. With over 25 years of experience, we deliver tailored solutions to streamline regulatory processes and ensure successful product launches.
About IUVO Consulting
FDA Regulatory Compliance. Simplified.
IUVO Consulting, LLC provides expert guidance to help medical device, drug, food, and cosmetic companies achieve and maintain FDA compliance.
At IUVO Consulting, LLC, we know FDA compliance can feel like an obstacle—but it doesn’t have to be. With 25+ years of experience, we make the process fast, efficient, and painless so you can get your product on the market and start generating revenue—sooner.
We’ve helped thousands of companies across medical devices, pharmaceuticals, foods, dietary supplements, and cosmetics clear regulatory hurdles, break into the U.S. market, and scale successfully. Our strategies streamline submissions, cut through red tape, and ensure compliance without the stress and delays.
You focus on innovation.
We’ll handle the compliance.
Why Choose
IUVO Consulting?
How can we assist you?
As your company's compliance consultant, IUVO Consulting will assist your firm with required U.S. FDA submissions and facilitate effective, productive communications between your company and the U.S. FDA.
IUVO Consulting
We Help You Succeed
IUVO Consulting, LLC provides expert guidance to help medical device, drug, food, and cosmetic companies achieve and maintain FDA compliance.
Regulatory Strategy & Submissions
510(k), De Novo, INDs, GDUFA, and more
Import & Export
Support
Facility registration, U.S. Agent services, and import detention assistance
FDA Compliance & Risk Management
Labeling reviews, Inspection support, and GMP compliance
Fractional Chief Compliance Officer Services
Strategic leadership for emerging companies
IUVO Consulting -
What we provide to our clients
At IUVO Consulting, LLC, we specialize in guiding companies through the complexities of U.S. FDA regulatory compliance. Our flat-rate, project-based approach ensures that you get your product on the market easily and quickly – and with no surprises.
FDA Regulatory Submissions
Navigating FDA regulations for drugs, foods, cosmetics, and medical devices can be challenging. We provide expert assistance to streamline your submissions:
Regulatory Strategy Development
We collaborate with your team to develop effective regulatory strategies that are aligned with your product pipeline and business objectives. Our goal is to enhance your market share in the U.S. by providing:
Real People. Real Stories
This company really acts with an outstanding view on customer experience. They help immediately, work quickly, and provide a lot of tools to ease export to the USA according to their laws and requirements.
Raquel Anton
This company really acts with an outstanding view on customer experience. They help immediately, work quickly, and provide a lot of tools to ease export to the USA according to their laws and requirements.
Raquel Anton