​Welcome

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HeteroGeneity (HG) is a Washington, DC-based consultancy and Scientific Management Organization.

HG provides strategic, technical "hands on" assistance to sponsors who are conducting 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.  

HeteroGeneity uses a 
"Whole Elephant"
​approach to product development: 

• ​​​Define the project = "ELEPHANT"
• Engage the project team
• Assess the current status
• Establish a strategic "blue print"  ​​

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News
Events
Publications
How can HG help?

• "Work" the strategy
• Follow the blue-print
• View the Whole Elephant
• ​Achieve the Product Development Goal   ​

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FDA Approves Special Green Tea Extract as a New Topical Drug for Genital Warts
Expert Says Development Marks the Birth of a “New Industry”

"Freddie Ann Hoffman, MD, an expert on this botanical drug process, said, “A new drug industry has just been born -- perhaps ‘reborn’ -- in the United States: the polymolecular botanical drug industry.” Dr. Hoffman is a former FDA official and is founder of
HeteroGeneity, LLC, a Washington, D.C.-based consulting firm advising companies seeking to market botanically-based drugs."

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