Regulatory Services
Specialist regulatory support for IVD and companion diagnostic studies, from early study strategy and planning through study conduct and close-out.
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The Regulatory Challenge
ARC helps diagnostic developers understand regulatory expectations, identify evidence gaps and maintain alignment across product development, clinical delivery and submission planning.
Product classification, intended use and submission routes can vary significantly between markets.
Scientific validity, analytical performance and clinical performance requirements must be understood early.
Technical and clinical documentation must remain complete, consistent and aligned with the intended claims.
Regulatory expectations continue to change across the UK, European Union, United States and other global markets.
Our Regulatory Services
ARC provides flexible regulatory support, from targeted input on a specific challenge to integrated delivery across the full diagnostic product lifecycle.
Regulatory strategy and pathway planning
Product classification, intended use and claims
Regulatory gap assessments
Global market and registration planning
FDA pre-submission and authority engagement
EU IVDR, UKCA and MHRA support
US and international regulatory submissions
Scientific validity and performance evaluation documentation
Clinical performance study protocols and reports
Post-market, lifecycle and regulatory intelligence support
Regulatory and quality alignment
Our Regulatory Capabilities
From early study planning and evidence strategy through clinical-study submissions, ARC provides practical regulatory expertise tailored to your programme.
Regulatory guidance aligned with each stage of diagnostic development.
Global Regulatory Support
ARC supports precision medicine clinical trialsthrough an extensive talent pool to deliverlocal expertise in a global study context.
Geographic coverage reflects ARC’s internal team and established delivery network. Regulatory support is tailored to each programme and target market.
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.
Focused experience across IVD, CDx and precision medicine programmes.
Regulatory, clinical, laboratory and medical writing expertise within one team.
Regulatory pathways shaped around your product, development stage and target markets.
Targeted support for one activity or integrated support across the lifecycle.
Explore expert perspectives, industry developments, and practical guidance across clinical research and CRO services.
Regulatory planning should begin as early as possible, ideally before key product-development, validation and clinical study decisions are finalised.
Yes. ARC can provide strategic pathway guidance as well as hands-on support with evidence planning, regulatory documentation, submissions and authority interactions.
ARC provides regulatory support across key markets, including the UK, European Union and United States, alongside wider international planning where appropriate.
Yes. ARC can assist with meeting strategy, question development, briefing documentation, meeting preparation and follow-up activities.
Yes. Support can include regulatory strategy, performance evaluation, technical documentation and wider submission-readiness activities under the EU IVDR.
Specialist expertise in precision medicine trials, regulatory compliance and clinical operations.
Connected Programme Support
ARC brings together regulatory, clinical, laboratory and technology expertise to support diagnostic programmes from development through delivery.
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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