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Regulatory and Quality Systems Consulting

The regulatory landscape is complex. We’re here for you, whether you need design and validation services or on-site support. We can help you with FDA quality system regulation (QSR) and ISO compliance, with clinical trials, or with commercializing products in various international markets.
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Research and Developmental Support

Whether you need chemistry testing services or a biological safety evaluation plan, we are your one source for every R&D support service. We develop and validate analytical methods and characterize new sterilization processes, help test and verify product performance, and provide advanced histological technology.

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Non-clinical Testing

When it comes to non-clinical testing, you can rely on our safety evaluation studies (in vitro and in vivo) on a variety of biomaterials, medical devices, and related products. We perform testing to evaluate biocompatibility, and we also offer comprehensive histopathological services.
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Clinical Research

We can assist you in any aspect of your clinical research efforts. Our experience includes a broad range of technologies, therapies, indications, and business strategies. We can help with clinical design and trial conduct, as well as investigations to assess device performance, possible secondary effects, and risk acceptability.
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Post-market Support

Your needs don’t end at product launch. We can help with activities like release or sterility testing, microbial identification, and environmental monitoring. Or count on our consulting services to provide post-approval and post-market clinical surveillance studies, adverse event reporting, and quality system support.
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