Device CRO NAMSA says Clinlogix will extend its global reach and expand its range of disease expertise.
The Ohio-based medical device contractor announced the acquisition of Philadelphia’s Clinlogix last week, framing the deal as the third in a trilogy of growth-focused takeovers behind the purchases of Syntactx and American Preclinical Services earlier this year.
NAMSA CEO Christophe Berthoux said bringing the firms together “offers medtech innovators a clear choice when seeking safe, accelerated clinical development and commercialization of life-changing medical products.”
This was echoed by Clinlogix CEO, JeanMarie Markham. “Now together, with NAMSA, we are expanding and leveraging our respective services to truly provide end-to end development solutions to our Clients.”
Like NAMSA, Clinlogix is focused on the medical device sector. The firm has been involved in more than 500 clinical trials at 3,500 sites around the world.
Clinlogix cites the “unparalleled” breadth and depth of global expertise as its key feature, highlighting its experience running trials in cardiovascular disease, neurology, nephrology, cancer and wound care as examples.
The takeover, like the purchases of Syntactx and APS, have been completed since French private equity investor Archimed bought a majority share in NAMSA though its MED Platform I fund.
US FDA nod
The Clinlogix deal follows just weeks after the US Food and Drug Administration (FDA) granted NAMSA Accreditation Scheme for Conformity Assessment (ASCA) status.
The ASCA Pilot Program, a first-of-its-kind conformity assessment program created by the US FDA, is designed to reduce the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency.
According to the FDA, the program “clears the first hurdle in the medical device premarket regulatory process for manufacturers submitting for clearance or approval to the FDA’s Centers for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).”
NAMSA claims it is the only US first and only ASCA-accredited biocompatibility laboratory in the US.
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