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Botanical Regulatory Consulting

Experts of FDA Regulations for Botanical Products

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Cannabis Products

Regulation of hemp-based CBD products in the United States is evolving rapidly.  It is important to address quality standards and manufacturing practices early in the development of your cannabis-based company.  Early implementation of proper practices into your company’s procedures ensures compliance without reducing the output or efficiency of your business model later down the line.  Whether you work with state-regulated recreational cannabis or hemp-based CBD, BRC can help your company with regulatory compliance. 

Herbal Products

Dietary Supplement Health and Education Act (DSHEA) regulations can be overwhelming for small business compliance, but BRC is experienced and can help you navigate the way.  We write regulatory submissions such as Generally Recognized as Safe (GRAS) and New Dietary Ingredients (NDI), petitioning FDA to approve conventional and qualified health claims for herbal product ingredients.  We design clinical trials for the substantiation of approved health claims on labeling.  We also support quality management systems, providing the foundation for compliance in current Good Manufacturing Practices (cGMP) and Good Agricultural and Collection Practices (GACP).

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Botanical Drugs

Botanical drugs are herbal products that are intended to diagnose, cure, mitigate, treat, or prevent disease in humans.  Botanical drugs are regulated in a similar manner as pharmaceutical drugs, requiring a prescription for distribution and sales in the US.  The regulation of botanical drugs also applies to researchers conducting clinical investigations on the therapeutic potential of botanical products.  Whether you are a researcher exploring the efficacy of a botanical product or you have commercial interest in a botanical drug, BRC is trained and experienced in botanical drug development. We specialize in writing regulatory submissions, developing clinical protocols and IRB submissions, composing strong CMC submissions, and establishing systems of good practices compliance.