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:
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Registering your establishment with the FDA.
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Maintaining and certifying the accuracy of your product listings.
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Assisting with the payment of annual Over-the-Counter Monograph User Fees (OMUFA).
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Providing support for Generic Drug User Fee Amendments (GDUFA) reporting requirements.
Get assistance with registration and listing your drug product.
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:
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Acting as your official correspondent with the FDA.
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Ensuring timely and clear communication between your company and the agency.
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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.
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Identify necessary modifications to align with regulatory standards.
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Assist in the design or redesign of labels to ensure clarity and compliance.
Have a label you need reviewed? Send it to us now!
Get Expert Guidance on Your Regulatory Strategy
Explore how we can help you design and execute your company’s regulatory strategy.