Your partner for Dx compliance in translational research

Diagnostics and patient

Diagnostics

Support for in vitro diagnostics regulations

Driving in vitro diagnostics advancements, from early development to digital solutions.
Early phase IVD development Experience in oncology and infectious disease IVD programmes.
Regulatory support for IVD Product approval processes tailored for in vitro diagnostics.
ARC360®: Your regulatory navigator A digital platform for global IVD clinical trial requirements.
ARC360®: Your lab toolkit IVD An online tool, ideal for an IVD study sponsor or an IND/IMP sponsor, developing a targeted therapy.

Join the diagnostics community that is already benefiting

How we can help diagnostics companies

Consultants

Regulatory compliance

Personalised pathways for in vitro diagnostics regulations.

  • Streamlining global diagnostics regulatory processes.
  • Efficient US submission strategies for IVD products.
  • Aligning commercialisation with business objectives.
  • Offering hands-on guidance for intricate global diagnostic regulations.
Medical test papers

Clinical trial management

Overseeing IVD development from initial concept to final results.

  • In-depth involvement in oncology and infectious disease IVD programmes.
  • Guidance from early-phase development to post-market surveillance.
  • Ensuring robust and compliant data capture and management.
  • Adapting to evolving diagnostic needs and industry shifts.
Scientist in lab

CRO Partnership

Accelerating diagnostics with expert clinical oversight.

  • Specialised focus on supporting in vitro diagnostics.
  • Ensuring readiness with QMS audit services tailored for diagnostics.
  • Guidance through complexities from protocol design to data management.
  • Risk management ensuring product safety and compliance.
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.

ARC Regulatory team
Scientist in lab
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

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