FDA Regulatory Mapping

Regulatory Mapping

H&A specializes in regulatory mapping.  We look at the marketplace, take into consideration the approvals and denials surrounding our client’s product genre, and prepare a comprehensive determination of the appropriate regulatory landscape.  Clients find this tool useful because it provides a layout the barriers and pathways for the market and allows them to develop their pipeline accordingly.

For emerging technologies H&A will help build a comprehensive regulatory strategy map, including approval or clearance options, testing, new uses, new indications, new patient populations, and will help develop persuasive FDA arguments to facilitate approval.