Cost-Effective, Efficient, Accelerating Market Access
At Abingdon Health, we provide end-to-end lateral flow development and manufacturing solutions under one roof.
Our integrated approach streamlines your journey from concept to commercialisation, eliminating the inefficiencies of managing multiple vendors. Saving you time and money and accelerating the path to market for your innovative product.
Development
Our expert scientists transform your biomarker into a precise, reliable lateral flow assay. Using cutting-edge technology and decades of collective experience, we optimize your test for sensitivity, specificity, and usability. Working collaboratively with your team, we create bespoke solutions tailored to your exact requirements.
Scale-Up & Manufacturing
Seamlessly transition from development to large-scale production without changing facilities. Our state-of-the-art manufacturing capabilities ensure consistent quality through validated processes. We maintain rigorous control across all production stages, from raw material handling to final packaging.
Regulatory Support
Alongside your development, we navigate on your behalf the complex regulatory landscape with our 45 -strong team. We provide comprehensive documentation support and guidance through CE marking, FDA approval, and other global regulatory pathways. Our quality management system ensures your products meet the highest standards worldwide.
Performance Evaluation
Validate your product’s performance with our meticulous evaluation services. Our dedicated analytical laboratory conducts thorough testing to confirm reliability and reproducibility, providing the evidence required for regulatory submission and build market confidence.
By integrating all these capabilities under one roof, we create parallel workstreams that accelerate your timeline while maintaining exceptional quality. This cohesive approach eliminates communication gaps, reduces transfer delays, and optimizes resource allocation—ultimately saving you time and money while expediting your path to market access.
Improving life by making rapid results accessible to all
Lateral flow testing is supporting the move away from laboratory methods towards point of care testing; thereby supporting faster decision-making and treatment.
Abingdon Health offers a comprehensive range of lateral flow CRO, CDMO and regulatory contract services. In essence, we provide our customers with a comprehensive lateral flow service solution to take their projects from idea to commercial success. We can take tests from concept through to routine lateral flow test manufacture or transfer in standard operating procedures and scale-up production quickly and accurately.
Abingdon Health is certified to ISO 9001 and ISO 13485, and is compliant to FDA 21 CFR 820 and GMP. Abingdon Health also meets regulatory requirements of UK MDR 2002, the IVDD 98/79/EC and the IVDR 2017/746. In addition, our facilities have an establishment registration with the FDA.
Industries we work with
Delivering access to rapid results across all industries
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Clinical
Point of care testing to support faster decision-making and results delivery
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Animal Health
Health monitoring and management on the farm or in a veterinary surgery.
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Plant Health
Keeping food safe to eat and helping to maintain yield.
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Defense
Protecting society from chemical and biological threats.
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Environment
Testing environmental contamination and toxins at the source.
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Pharmaceutical
Supporting patient-centricity alongside precision medicine and clinical trial decentralisation.
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Food
Lateral flow tests already play a pivotal role in ensuring food safety across many sectors of the food industry.
