ARC Regulatory

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.

Our mission is to deliver platinum-quality life-cycle support solutions for every one of our client organisations. ARC Regulatory 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.

Our 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 medical device organisations throughout Europe and beyond, from start-ups to Top 10 multi-nationals. Here’s how we tailor our service to suit customer needs:

For early stage companies, we 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, our experience complements in-house expertise, assisting with specific project or compliance activities. We also provide training for senior personnel, and execute internal audits of client cGMP quality systems.

We take an integrated and collaborative approach to ensure we deliver commercially-focused compliance solutions for all of our clients.

ARC Regulatory are active members of MedTech Europe & BIVDA, and participate in ISO Technical Committees 212 & 210 for medical device standards development.

Visit www.arc-regulatory.co.uk to find out more, tel. +44(0) 28 7963 9304 or email [email protected]

Company’s Keywords:

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