ARC Regulatory ranked in Top 5

Ranked in the Top 5 InVitro Diagnostic Solution providers in the UK by MD Tech Review, their primary focus is to help both pharma and diagnostics companies in bringing targeted therapies to market.

ARC Regulatory’s primary focus is to help both the pharma and diagnostics manufacturers bring targeted therapies to market and its ethos is hinged upon ensuring patient safety, the integrity of study data, and compliance with local regulations.

Addressing their accolade, CEO Seamus Kearney explained: “Our philosophy is to work as a fully integrated partner to help our clients develop products that are safe, life-sustaining and bring hope to people with serious life-threatening disease. We also work with general medical device companies across EU Medical Device Regulation readiness and supporting responses to the Covid-19 pandemic.”

Most notable in the pandemic response is ARC’s expertise and oversight to support fellow local business, Bloc Blinds, as they pivoted their business to deliver much needed PPE equipment to support the front line against Covid-19.

He continued: “We are in the somewhat unique position, for a small company, to have representation in all regions of the world and can offer a truly expert and flexible solution to our sponsor organisations.

“So, whether we are working with a large global pharma partner, struggling to understand what they need to do conduct an IVD concordance study in China, or a smaller biopharma initiating their first precision medicine trial in the US, we are able to deliver clear, unambiguous advice and then work to develop a globally compliant IVD/CDx device protocol, gain regulatory approvals for the study, identify and qualify research laboratories and initiate and monitor the research studies through to close out and study reporting.

“Receiving this recognition couldn’t come at a better time as we move into a new phase of growth as we extend our team with new hires locally and our upcoming rebrand that speaks to the evolution of our company and our ambitions for the future”.

With the additional complexity of the changing regulatory landscape brought about by Brexit, the new EU Medical Device Directive and In vitro Diagnostic Regulations, right now ARC’s unique mix of expertise and geography are perfectly placed.

Visit arc-regulatory.co.uk

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