ARC Regulatory COTM

HIRANI ARC Regulatory

ARC Regulatory, a niche ‘First In Human’ consultancy specializing in global regulatory and clinical research solutions, has evolved significantly since its founding in 2010 by Seamus Kearney. ARC also offers a full CRO service to the precision medicine and in vitro diagnostic medical device industry and a suite of digital products so customers can self-serve to meet their immediate needs.

The company, which originated in Moneymore, Northern Ireland, has experienced a remarkable journey marked by key milestones. Today, the H/Q sits at the heart of the Titanic Quarter at the home of innovation, Catalyst.

ARC Regulatory today cherishes its origins in the pursuit of advancing medical discoveries and improving patient care. In recent years, the company has expanded its portfolio to include ARC360 Software as a Service (SaaS), offering a valuable tool to navigate the complex regulatory landscape for IVD/CDx clinical trials.

More recently, ARC launched the first Diagnostic and full-service CRO specifically tailored for IVD customers. This accomplishment underscores the company’s dedication to staying at the forefront of industry needs and providing comprehensive solutions to big pharma.

ARC’s mission is simple. From its headquarters in Belfast, Northern Ireland, it actively supports companies from the world’s big pharma players to diagnostic firms and novel start-ups, in the search to find kinder patient treatments. Both customers and ARC are committed to bringing innovative, patient-centric solutions to the market faster while maintaining the highest of quality for the end users: patients. 

ARC is proud to have recently received gold level status from Innovate NI for regulatory software ARC360. The ARC360 platform provides a comprehensive suite of tools that allows companies to manage numerous aspects of their IVD compliance in one place, providing country specific requirements for IVD Clinical performance studies. Innovation is at the heart of ARC Regulatory and we strive to improve patient lives for the better.

Heather Taylor, Chief Commercial Officer at ARC tells us “Northern Ireland is an ideal market for innovation within in vitro and companion diagnostics.  There’s an active life sciences cluster and it’s really supported by our friends at Invest in Northern Ireland. ARC is proud to call N. Ireland it’s home. We have a great deal of local talent in Belfast and beyond.” 

Heather shares that “Having spent 20 years in life sciences, ARC’s mission really aligns with my own values. My role is two-fold. I’m responsible for building our new commercial department with talent in sales and marketing areas and at the same time, bring novel marketing strategies together to a) build our brand and b) generate increased interest in our existing and new products. From the moment I joined the team in early ’23, I’ve seen incredible commitment from employees in both N. Ireland and around the world as we actively support big pharma, diagnostic firms, and start-ups. There’s never been a better time to join our team as we expand at home and abroad.”

Upcoming projects for ARC regulatory include:

  1. IVD Webinar Series on LinkedIn:

Stay tuned for ARC Regulatory’s insightful IVD webinar series on LinkedIn, offering the latest updates in the in vitro diagnostic field.

  1. Biomarkers UK – 29th Feb – 1st March, London:

ARC Regulatory are actively participating in Biomarkers UK where our Senior Clinical Project Manager Emma Lowe will be speaking and our other industry SME’s will be in attendance also at our stand.

  1. HIRANI Health Tech Spring Event – 29th-30th April, Belfast:

Join ARC Regulatory at the HIRANI Health Tech Spring Event for networking and discussions on health technology.

  1. AACR – 5th – 10th April, San Diego:

ARC’s Business Development lead, Martin Krainz, will represent the company at AACR, contributing to advancements in cancer research.

Find out more about ARC regulatory on their website and LinkedIn. 

Latest webinar series available: ARC Regulatory Webinars | Clinical Trial & Precision Medicine (

Video selection inc ARC360 reg navigator animation: ARC Medical Regulatory Videos | CRO | IVD | Clinical Trial Videos (

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