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BioReg experts can assess whether your product qualifies for the homeopathic route, advise on product claims and labeling and finally register your product in FDA as a homeopathic drug.
“Homeopathic drug product” as a drug product that is labeled as “homeopathic” and is labeled as containing only active ingredients and dilutions (e.g., 10X, 20X) listed for those active ingredients in the Homeopathic Pharmacopeia of the United States (HPUS).
See our blog on homeopathic products here.
The first step in assessing a potential homeopathic product is to check whether its active materials are listed in the Homeopathic Pharmacopoeia of the United States (HPUS) in their official monographs.
Each product’s active materials should comply with strength, quality, and purity as outlined in the HPUS and other international homeopathic compendia such as the German Pharmacopoeia, French Pharmacopoeia, or European Pharmacopoeia. In addition, the regulatory assessment should include whether the used biomarkers of the plant materials are similar to the “standard” plant material as specified in the HPUS.
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