ARC Regulatory

ARC Regulatory is a Medical Device Consultancy and Clinical Research Organisation that specialises in the delivery of compliant solutions to complex regulatory issues for companies in the medical device and in vitro diagnostic medical device industries. 

ARC Regulatory has a specific focus on in vitro diagnostic (IVD) medical device consultancy and a significant proportion of our clients are leaders in the IVD medical device industry. ARC Regulatory’s IVD medical device team has significant experience across multiple technologies and disease areas from self-test blood glucose monitoring, POC testing, blood borne virus and tissue transplant assay systems including complex, software driven instrumentation.  

Our Companion diagnostics team is focused on the complex issues surrounding Dx enabled therapies and drug-diagnostic co-development. In an era of significant and ever-increasing personalisation of new and on-market therapy assets, ARC Regulatory has the technical expertise and clinical-regulatory know-how to assist both diagnostic and pharma manufacturers develop and deliver upon an effective Dx strategy. 

In addition, our CRO business are industry leaders in companion diagnostic clinical study monitoring, providing local or regional expert CRA services to CDx study sponsors.