5611 16th Street NW
Washington, DC 20011-6809
United States
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Copyright HeteroGeneity, LLC - 2014. All rights reserved.
 

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

 

HG provides strategic, technical and "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.  

 

"Whole Elephant"

We take a "whole elephant" approach to product development:
  • Define the "ELEPHANT"
  • Engage the project team
  • Assess the current status
  • Establish a strategic "blue print"
  • "Work" the strategy
  • Follow the blue-print
  • View the Whole Elephant
  • Achieve the Product Development Goal
  • Product Development Goal
    HeteroGeneity works with sponsors to address difficult and often novel regulatory issues.