ARC Regulatory, a leading global specialist in research compliance for precision medicine clinical trials, has announced the launch of its new Laboratory Services division, supported by a £3 million self-funded investment in a state-of-the-art laboratory at its Belfast headquarters. This expansion alongside a recruitment campaign to double its 25 strong workforce marks a significant milestone in ARC’s commitment to providing comprehensive, end-to-end clinical trial support for implementing diagnostic tests in to precision medicine trials.
Located within Catalyst, Northern Ireland’s premier innovation hub, ARC Regulatory has built a reputation for facilitating the smooth and efficient progression of life-changing therapies through complex regulatory pathways. The newly established lab is currently staffed by a team of 7 experts from the precision medicine sector, further strengthening ARC’s capabilities in assay validation, clinical trial sample testing, and delivering clinical performance studies for complex in vitro diagnostic tests.
Seamus Kearney, the CEO and founder of ARC Regulatory, brings over two decades of experience in regulatory affairs and clinical research. Under his leadership, and with Dr Lindsey Bennie as Lab Manager, ARC has evolved into a global leader in regulatory compliance for precision medicine trials.
Seamus Kearney said, “The launch of our new Laboratory Services marks a transformative milestone in our mission to redefine regulatory support for precision medicine. By integrating cutting-edge laboratory capabilities with our existing regulatory and clinical operations expertise, we are providing clients with an unrivalled, end-to-end solution for global clinical trials. This expansion enables us to offer seamless assay validation in compliance with international regulatory standards, manage regulatory submissions and approvals for the research and deliver the in vitro diagnostic clinical study in accordance with international good clinical practice guidelines, fulfilling a significant gap in the early phases of clinical development of targeted precision therapeutics.
“We strategically chose Belfast as the location for our lab, leveraging its state-of-the-art facilities and the exceptional talent pool of scientists from across the UK and Ireland. Our investment not only enhances our service offering but also reinforces Belfast’s position as a hub for research excellence in precision medicine. By expanding our capabilities and growing our team, we aim to drive forward innovation in regulatory science while supporting the life sciences sector both locally and globally.”
ARC Regulatory’s investment in laboratory services underscores its commitment to innovation and excellence. With this new capability, ARC now offers First-in-Human (FiH) clinical sample testing, assay verification, and in-house regulatory compliance, ensuring streamlined, expedited trial execution supported by a team of globally renowned experts in regulatory compliance and good clinical practice.
The company, which currently employs 25 staff across the UK has ambitious plans for growth. ARC is actively recruiting an additional 25 team members this year including extending its laboratory team to support its expanding operations and is set to establish a new subsidiary sales office in Boston, further solidifying its global presence.
ARC’s impact extends beyond regulatory innovation, contributing significantly to the regional economy by positioning Belfast as a global hub for precision medicine expertise. Through job creation, industry collaborations, and knowledge-sharing initiatives, the company continues to drive forward innovations in clinical trial management. Its award-winning study submission and regulatory intelligence platform, ARC360, is transforming how companies manage clinical research approvals.
With a track record of supporting over 90 precision medicine trials for leading pharmaceutical and diagnostic firms, ARC has established itself as a key player in the sector. The launch of its new lab services marks another milestone in the company’s mission to accelerate the delivery of life-saving treatments to patients worldwide.
More information can be found at www.arc-regulatory.com