About Us
Precision medicine has the potential to transform patient care – but delivering it requires Sponsors to navigate complex clinical, diagnostic and regulatory requirements across global studies.
ARC was founded to help pharmaceutical and biotechnology companies manage that complexity with specialist IVD/CDx expertise and clear ownership across the clinical development pathway.
By connecting clinical research, accredited laboratory services and regulatory technology, we help Sponsors reduce complexity, manage risk and maintain greater clarity and control as studies move forward.
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Expertise with patients in mind
Our team brings specialist IVD/CDx, laboratory and regulatory expertise to complex clinical programmes, helping Sponsors make informed decisions and keep studies moving with clarity and confidence.
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Founder with 17 years’ experience leading IVD design engineering projects globally.
Pharma leader with 10 years’ experience managing IVD clinical research programmes.
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Chartered Accountant with 10+ years’ experience leading finance and governance functions.
10+ years’ experience delivering digital products across healthcare, data and regulated industries.
Brings over 10 years’ experience in clinical, quality and regulatory consulting for global precision medicine studies.
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30+ years’ expertise in people leadership, organisational development and culture.
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9 years assay development & validation experience. 3 years early phase clinical trials.
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20+ years’ expertise in global regulatory affairs and clinical compliance across pharmaceuticals and diagnostics.
12+ years of experience in diagnostics, clinical trials, NGS, and biomarker discovery.
Research operations leader experienced in diagnostics, pharmaceuticals, quality assurance, and project management.
Research operations leader experienced in diagnostics, regulated laboratories, biomarkers, and project delivery.
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Quality leader with 20+ years’ experience in regulated healthcare environments.
Chartered Biologist experienced in laboratory operations, technical management, quality, and regulatory compliance.
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IVD specialist with 14 years’ experience developing small molecules and ADA programmes.
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10 years commercial experience across pharma, sterile IV manufacturing and precision diagnostics.
Our Approach
At ARC Regulatory, trust and respect shape every partnership we build. We understand that behind every process, submission, and decision, there is a patient who matters. That is why we approach every piece of work with care, clarity, and a deep sense of responsibility.
We build confidence through clear communication, dependable support, and a commitment to doing things properly.
Speak directly with our experts for clear, actionable advice on your regulatory needs.
We work with professionalism, empathy, and respect for the organisations, teams, and responsibilities we support.
Be part of a specialist team helping to move precision medicine studies forward. At ARC, you’ll work across complex clinical, diagnostic, laboratory and regulatory challenges where your expertise can make a meaningful contribution.
Discover more expert perspectives, industry updates, and practical guidance from the ARC team.
The ARC team welcomes the opportunity to connect with you, share our real-life experiences and help navigate your business as you find kinder patient treatments.
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