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Drug Regulatory Compliance Services

At IUVO Consulting, LLC, we specialize in assisting companies with U.S. FDA regulatory requirements for drug products.

Annual Compliance

Annual Registration & Drug Product Listing

The FDA mandates that manufacturers, repackagers, relabelers, and other relevant entities register their establishments and list their drug products annually between October 1 and December 31. We facilitate this process by:

01

Registering your establishment with the FDA.

02

Maintaining and certifying the accuracy of your product listings.

03

Assisting with the payment of annual Over-the-Counter Monograph User Fees (OMUFA).

04

Providing support for Generic Drug User Fee Amendments (GDUFA) reporting requirements.

Get assistance with registration and listing your drug product.

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Resolve Detained Product Issues

Detained Product Assistance

If your products are detained upon entry into the U.S. due to non-compliance with FDA regulations, we can help by:

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U.S. Agent Designation

Foreign companies are required to appoint a U.S. Agent to liaise with the FDA. Our U.S. Agent services include:

01

Acting as your official correspondent with the FDA.

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Ensuring timely and clear communication between your company and the agency.

03

Assisting with regulatory inquiries and compliance matters.

Designate IUVO Consulting as your U.S. Agent.

Drug Product Labeling Review and Design

Accurate labeling is crucial for FDA compliance. Our experts will:

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Review your product labels to ensure they meet FDA requirements pertaining to monograph requirements, warnings, active ingredient declarations, usage instructions, and more.

02

Identify necessary modifications to align with regulatory standards.

03

Assist in the design or redesign of labels to ensure clarity and compliance.

Have a label you need reviewed? Send it to us now!

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Get Expert Guidance on Your Regulatory Strategy

Explore how we can help you design and execute your company’s regulatory strategy.

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About IUVO Consulting

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

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