Laboratory
Lab and health institution support
Ensuring rigorous lab compliance and safety from study planning to patient testing.
End-to-end study management
From initial planning to final validation, overseeing all stages of drug and device performance studies.
Ongoing compliance monitoring
Dedicated oversight of sites, ensuring consistent adherence to standards and patient safety.
Expertise in IVDR adaptations
Navigating the evolving IVDR landscape, from regulatory updates to CE mark requirements.
Addressing regulatory exemptions
Guiding labs and health institutions through Article 5 (5) of IVDR in-house exemptions.
Join the laboratory community that is already benefiting
How we can help laboratory companies
Regulatory lab compliance and analytical testing
Ensuring your laboratory operations meet the highest regulatory standards and test results are meaningful.
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Detailed guidance on laboratory regulations.
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Efficient navigation through approval and certification processes.
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Hands-on assistance with laboratory equipment and software compliance.
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Adaptation to evolving regulatory landscapes with proactive updates.
Clinical trial management for laboratories
Full-spectrum support, from study inception to post-trial evaluations.
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Expert planning and execution of laboratory-based clinical trials.
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Robust data management and interpretation for accurate trial outcomes.
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Oversight of trial sites ensuring standard adherence and patient safety.
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Streamlined clinical evaluation and validation of laboratory test results.
CRO partnership for laboratories
Leveraging our specialised expertise to optimise laboratory functions.
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Dedicated CRO services tailored for laboratory needs and challenges.
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QMS audits to ensure lab readiness.
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Comprehensive risk management to ensure product and process safety.
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Expert guidance on SOPs and best practices.
Our Story
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.
Customer Story
“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.”
Erica Kremer, Director Compliance at GenDx
Latest News & Insights
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02/09/2024
