HeteroGeneity, LLC provides advice and strategies to companies, investigators, Institutional Review Boards (IRBs), and other entities regarding the regulation of foods -- including dietary supplements and foods for special dietary uses (Medical Foods), nonprescription (Over the Counter, OTC monograph) and prescription drugs, biologics (cytokines, biotech, vaccines), cosmetics and medical devices.

• How can I market my product in the United States?
  
• What is my product:  food -- dietary supplement -- drug?
  
• What kinds of "claims" can I make to promote the sale of my product?
  
• How do I protect my product from competitors?
  
• Should I develop this product?  --invest in this product? 
  
• How can I sell my product while I am still developing it?
  
• The Food and Drug Administration (FDA) sent me a Warning Letter, "Courtesy Letter," Inspection Form 483.   How do I address the agency's comments?
  
• Do I need to file an Investigational New Drug (IND) application?
  
• How do I file an IND, New Drug Applications (NDA), Drug Master File (DMF)?
  
• How can this product satisfy the FDA requirements for Safety and Efficacy?
  
• What is the fastest track to the marketplace? 

HeteroGeneity, LLC can address your questions on product development and help you define strategies for entry into the US marketplace.