Overview

ARC is a Medical Device Consultancy and Clinical Research Organisation that specialises in delivering compliance excellence for companies in the IVD and Companion Diagnostics (CDx) sectors. ARC's mission is to deliver platinum-quality life-cycle support solutions for each client. It supports companies at every stage of the product life-cycle, from technical and clinical feasibility, product development through approval to post market surveillance and clinical performance follow-up. ARC's expertise includes: Companion Diagnostics IVDs Regulatory Strategy, Alignment & Submissions Clinical Project Management, Protocol Development and Report Writing Clinical Operations including site set up and Global Study Site Monitoring Medical Device Clinical Quality Assurance Biostatistics - Study design and Data Analysis Quality Management Usability & Risk Management We work with pharma and medical device organisations globally from start-ups to Top 10 multi-nationals. Services are tailored to suit customer needs: For early stage companies, ARC experts help define the most appropriate strategic plan to successfully launch a high-quality, safe and effective new product; and to enter into new global markets. With larger companies, ARC's experience complements in-house expertise, assisting with specific project or compliance activities. The global team provides training for senior personnel, and execute internal audits of client cGMP quality systems. ARC's approach remains consistent: an integrated and collaborative approach to deliver commercially-focused compliance solutions for all of its clients, big and small. ARC Regulatory is an active member of MedTech Europe & BIVDA, and participates in ISO Technical Committees 212 & 210 for medical device standards development. Visit www.arc-regulatory.co.uk to find out more. Alternatively, call+44(0) 28 7963 9304 or email info@arc-regulatory.co.uk