HeteroGeneity (HG) is a Washington, DC-based consultancy and Scientific Management Organization.
HG provides strategic, technical and "hands on" assistance to sponsors who are conducing research development, and commercialization of healthcare products: drugs, biologics, dietary supplements, foods for special dietary uses ("Medical Foods"), medical devices- for the United States and Canadian markets.
We specialize in the regulation, policy and science of
complex, heterogeneous mixtures, such as botanicals, marine oils, biologics. We address the novel areas of herbals, fish oils probiotics, and products from Traditional Medicine Practice (TCM, Ayurveda, etc.), as well as other naturally or historically complex products.
Working at the frontier of regulation, HG was instrumental in achieving the FDA New Drug Application (NDA) approvals for the Botanical New Drugs for the United States market.