Ensure safe import and market approval for your dietary supplements with FDA CertPRO. Our expert regulatory team helps you achieve and maintain full FDA compliance—seamlessly and stress-free.
Register with FDA
Ensuring compliance with U.S. Food and Drug Administration (FDA) regulations is crucial for dietary supplement manufacturers and distributors aiming to import and market their products safely. At Consult CertPRO, our team of regulatory professionals is dedicated to helping you achieve and maintain compliance, ensuring your dietary supplement facility operates within FDA guidelines.
With decades of combined industry experience, we assist both domestic and international dietary supplement manufacturers in navigating complex regulatory landscapes. Our services include:
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We provide prompt and affordable assistance with facility registration, renewal, and Data Universal Numbering System (DUNS) number acquisition. Our services also encompass U.S. Agent representation and access to our MyFDA platform, facilitating easy compliance management.
Given the dynamic nature of FDA requirements for dietary supplements, our regulatory specialists conduct thorough reviews of your product labels and ingredients. We offer detailed reports with recommended changes, ready-to-use graphic files of compliant labels, and personalized guidance to ensure adherence to current regulations.
To protect public health, the FDA mandates advance notice for every imported shipment. We assist in gathering necessary documentation, adhering to strict submission guidelines based on your shipment’s transport method, and navigating Prior Notice submission systems. Our Prior Notice Express service allows for the secure and efficient filing of multiple notices.
Manufacturers are required to develop and implement MMRs for each unique formulation and batch size. These records outline manufacturing process steps to ensure consistency in components, quality, labeling, and packaging of each supplement batch. Our food safety specialists review your facility’s MMRs to assure ongoing FDA compliance.
We act as your U.S. contact to facilitate timely forwarding of adverse event reports, ensuring compliance with FDA requirements and maintaining consumer safety.
In cases where shipments are delayed or held by the FDA, our team provides support to address the issues promptly, facilitating the release of your products.
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture, process, pack, or hold food (including dietary supplements) for human or animal consumption in the U.S. are required to register their facilities with the FDA, unless exempt under specific regulations. This requirement applies to domestic facilities regardless of whether their products enter interstate commerce.
Certain facilities may be exempt from FDA registration; however, specific exemptions depend on various factors outlined in the Code of Federal Regulations. It's essential to consult with regulatory experts to determine if your facility qualifies for an exemption.
At Consult CertPRO, we are committed to guiding you through the complexities of FDA regulations, ensuring your dietary supplement products comply with all necessary requirements for successful market entry and distribution.