NAMSA, the Northwood, Ohio-based medical device research organization, has said guten tag to Germany. The company has opened its newest office near Frankfurt. Staff with regulatory and quality expertise, clinical managers and local monitors will provide support for European clinical trials as well as European device makers seeking approvals in the United States, according to the company.
This isn’t, however, the firms first foray into Europe. NAMSA’s testing laboratory near Lyon, France, has been conducting non-clinical safety and efficacy studies for medical device companies since 1986.
“U.S. companies can have confidence that the high quality support they’ve valued in NAMSA’s U.S. clinical and consulting operations are now available in Europe, ensuring the same responsiveness and thoroughness on both sides of ‘the pond,’” said Elizabeth Kempen, chief operating officer of NAMSA's clinical research and consulting groups.
European market approval has emerged as a preferred pathway for medical device manufacturers primarily due to more efficient approval processes, Kempen claimed.
“The placement of this office reinforces NAMSA’s commitment to helping our clients design and execute global regulatory and clinical strategies, develop new therapies, and launch them in the most efficient manner possible,” said John Gorski, NAMSA’s president and CEO. “The combination of non-clinical and clinical research expertise at our European locations enables NAMSA to provide our clients with a higher level of continuity, consistency and convenience throughout the product development process.”
NAMSA provides range of services to prove efficacy, non-clinical and clinical safety of medical devices, IVDs and combination products.