Diagnostics
Support for in vitro diagnostics regulations
Join the diagnostics community that is already benefiting
How we can help diagnostics companies
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Streamlining global diagnostics regulatory processes.
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Efficient US submission strategies for IVD products.
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Aligning commercialisation with business objectives.
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Offering hands-on guidance for intricate global diagnostic regulations.
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In-depth involvement in oncology and infectious disease IVD programmes.
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Guidance from early-phase development to post-market surveillance.
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Ensuring robust and compliant data capture and management.
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Adapting to evolving diagnostic needs and industry shifts.
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Specialised focus on supporting in vitro diagnostics.
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Ensuring readiness with QMS audit services tailored for diagnostics.
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Guidance through complexities from protocol design to data management.
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Risk management ensuring product safety and compliance.
From Lab to Life™
Recognising the need for a more robust strategic approach to medical device consultancy, ARC Regulatory was established in 2010 by Seamus Kearney. The primary goal was to ease the journey towards regulatory compliance for companies specifically in the in vitro and companion diagnostic industries. Since it’s inception, the company has enlarged its portfolio to include regulatory quality and clinical consultancy, providing CRO services and offering digital solutions to navigate today’s regulatory landscape at home and abroad.
“At GenDx, we really appreciated the support and guidance provided by the ARC Regulatory team for our projects. Our overall experience has been very positive and the ARC team has shown to be very knowledgeable, responsive and collaborative. A great team to work with.”