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Product Classification

Is your product a drug? A device? A biological product? A combination product? Let's find out.

Determining your product’s classification is a key decision that will define its regulatory pathway to the marketplace. Our experienced team of consultants will guide you through the classification process, up to and including developing a Request for Designation (RFD) to the FDA.

Regardless of where you plan to sell or distribute your product, we can design strategic plans that lay out potential regulatory pathways to achieve your marketing objectives in the selected markets of interest


To determine your product's classification, we ask these questions:

  • Who will use your product?
  • How do you want people to use your product? What is the intended use?
  • What patient population do you want your product used in? What is the indication for use?
  • What product benefits do you wish to claim? What are the product claims?
  • What is your product’s composition?


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