top of page
hero_bg.png

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.

about_us_img.png

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

We_Help_You_Succeed.png

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:

drugs_img.png

Drugs

Annual registrations, product listings, labeling reviews, and U.S. Agent services

Medical_Devices.png

Medical Devices

510(k) and 513(g) submissions, pre-submission meetings, De Novo requests, establishment registration, product listing, and labeling reviews

Foods_&_Dietary_Supplements.png

Foods & Dietary Supplements

Food Facility registrations, prior notice submissions, and labeling compliance.

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:

Complete the form and let us know how we can help you design and execute your company's regulatory strategy

MAIN COMPANY FUNCTION(S) Required

Thanks for submitting!

cta_bg.png

At IUVO Consulting, LLC, the phrase “We’re Here to Help” is more than a slogan. Our name – “iuvo” – is the word for “help” in Latin, and it is the hallmark around which our organization is built. 

Real People. Real Stories

review_star.png
review_stars.png
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

review_stars.png
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

IUVO_footer_logo.png

About IUVO Consulting

IUVO Consulting, LLC provides expert guidance to help medical device, drug, food and cosmetic companies to achieve and maintain FDA compliance.

Stay Connected

Join our newsletter and stay updated on the latest trends in digital design.

Thanks for submitting!

@2025 IUVO Consulting. All Rights Reserved.

bottom of page