ARC Regulatory
The Regulatory Expert for Companion Diagnostics Development

Ongoing regulatory developments in the dynamic in vitro diagnostics (IVD) field, especially for companion diagnostics (CDx) and precision medicine, creates a challenging environment for pharmaceutical and diagnostic companies. They need an expert hand to guide them through the regulations to ensure diligent compliance in therapy and diagnostic co-development.

ARC Regulatory brings this expertise as a regulatory consultancy and clinical research organization (CRO) specializing in IVDs with a strong focus on CDx. It plays a pivotal role in advancing precision medicine by assisting partners during the early phases of CDx development. It also recognizes the challenges diagnostic vendors face in adapting to changing regulations, particularly in the EU, and helps them understand and comply with the intricacies of the In Vitro Diagnostic Regulations (IVDR).

“We provide the necessary expertise to help our partners navigate IVD regulations and successfully execute their diagnostic studies while ensuring compliance,” says James Lappin, Head of Clinical Compliance and Quality Assurance at ARC Regulatory.

ARC offers a wide range of services, including CDx trial site selection, site initiation and study monitoring. It helps clinical trial sponsors develop study protocols andother essential documents, and carry out study applications in the EU, the U.S. and further afield, facilitating a seamless transition from study setup to closeout and report generation. It has extensive knowledge and experience supporting partners in CDx studies, particularly in the Phase I & II stages of co-development.

ARC Regulatory’s clinical research associates (CRAs) ensure rigorous monitoring of good clinical practices (GCP) and regulatory compliance. One of the company’s core strengths lies in its exceptional monitoring capabilities, offered through a global network of professionals across the EU, Asia and the U.S.

ARC Regulatory safeguards the interests of pharma partners by validating their diagnostic vendor’s capabilities in CDx development and study execution. From a quality management perspective, it conducts due diligence audits for diagnostic vendors, ensuring adherence to good manufacturing practices and GCP standards. It helps clients to implement and maintain their ISO 13485 quality management systems (QMS) for medical device development, as well as ISO 17025/15189 QMS implementation for laboratories.

Recent success stories include: providing clinical study management and monitoring services to an established diagnostics manufacturer, playing a key role in generating robust clinical data to support CE-marking and premarket approval (PMA) with a CDx indication in the US; helping a partner plan and implement an ISO 17025 QMS for their laboratory, including preparation for a successful accreditation audit; and developing a regulatory strategy and first US pre-submission for a new diagnostic company with a novel device.

We provide the necessary expertise to help our partners navigate IVD regulations and successfully execute their diagnostic studies while ensuring compliance

ARC Regulatory has also consolidated its knowledge and expertise in CDx within the ARC360 software-as-a-service (SaaS) platform. This tool aids Sponsors in understanding the requirements for starting CDx and IVD studies in over 40 countries worldwide and includes an expanding learning management platform addressing important IVD clinical and regulatory topics.

ARC Regulatory’s success stems from an expert team comprising a diverse range of professionals with expertise in regulatory consultancy, quality management, and assay development. Their extensive backgrounds in precision medicine, CDx market launches, and various device technologies (e.g. qPCR and next-generation sequencing (NGS)) form the basis of the company’s robust knowledge bank. The team brings a holistic perspective on regulatory and quality requirements in the IVD space.

Bridging the gap between pharmaceutical companies and diagnostic vendors, ARC Regulatory positions itself as the trusted global partner for study sponsors seeking to understand and navigatethe regulatory landscape for CDx studies in the realm of precision medicine.