Challenge

A world-leading manufacturer of wound care products was assessing opportunities in advanced wound care, and had mapped regulatory pathways relating to various classes of product.

Having identified various paradigms for currently marketed products in the US, including 510(k), Class III PMA, banked human tissue, Biologics License Application, and New Drug Application, the company needed to understand the corresponding regulatory pathways in Europe, and the regulatory requirements for bringing three of its products to market.

Solution

For this project, we handpicked a regulatory wound care specialist consultant, who was previously an MHRA assessor, to conduct this project. The final output included:

  • descriptions of the considerations used to classify each product into the appropriate regulatory class
  • risks and uncertainties in such classification and how these may evolve over time
  • data and documentation requirements likely to be needed for licensure
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