About the Case Study
Download the Case Study
Solvay Specialty Polymers USA, LLC, a worldwide provider of biomaterials, is the leader in serving diversified markets around the globe. Traditionally, Solvay has been a supplier of biomaterials to the healthcare sector, but recently identified a significant market opportunity within the dental marketplace.
Recognizing a strong need for new and innovative materials within the denture sector, Solvay sought to accurately assess the market opportunity for a polymer solution while also evaluating the associated product development and commercialization requirements, timelines and costs.
To assist with the development of this novel device, Solvay required a clinical research organization (CRO) that possessed vast dental product expertise and also had deep-rooted experience in successfully navigating the U.S. Food & Drug Administration (FDA) 510(k) submission pathway for first-time market entrants.
We invite you to access this case study to learn how NAMSA’s MRO Approach delivered Solvay 12 months and $7.5M in 510(k) development savings.