Wound care – regulatory support

10111A world-leading manufacturer of wound care products was assessing opportunities in advanced wound care, and has mapped regulatory pathways that pertained to various classes of product. Having identified various paradigms for currently marketed products in the US including 510K; Class III-PMA; Banked Human Tissue; Biologics License Application; and New Drug Application, Alacrita was asked to set out the corresponding regulatory pathways in Europe, and to describe the regulatory requirements for bringing three of the client’s products to market.

For this project, Alacrita hand-picked a regulatory wound care specialist consultant who was previously an MHRA assessor from within its associate network 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; as well as data and documentation requirements likely to be needed for licensure.

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