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Classification and Regulatory Pathway Strategy

Is your product a drug? A device? A biological product? A combination product? Your product’s classification determination is a key decision that will define your product’s regulatory pathway to the marketplace.

To determine classification, you need to ask 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?

RQMIS can guide you through the classification process, up to and including developing a Request for Designation (RFD) to the Food and Drug Administration (FDA). We design regulatory strategic plans that lay out potential regulatory pathways to achieve your marketing objectives in the selected markets of interest.

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