From a small family run business, Hart Biologicals has grown into a strong and thriving biomedical company with customers around the globe. Started in 2002 with the core mission to manufacture and supply the Manchester Capillary Reagent, today contract manufacturing is an integral part of Hart Biologicals service offering. We work with a wide range of partners to help them create and develop high quality products that are suitable for customers’ specific and defined needs.
Hart Biologicals has extensive industry experience of instrument and reagent manufacturing. With an expert team and specialist equipment we can provide exactly what our clients need. Solution-driven R&D team will work with you to help define your problem, find a resolution, identify your specific project needs and ensure that all necessary registrations are in place to accelerate time to market for our partner’s products.
You can be confident that with our help, you will be able to demonstrate safe compliance within all necessary regulations, for all stages of the product life-cycle.
Hart has a variety of instrument and reagent manufacturing capabilities. Working with both small and large-scale batch sizes, we work efficiently and help to reduce waste during the production process. All of our manufacturing takes place at our state-of-the-art Hartlepool headquarters. This gives us end-to-end control over products, processes, and documentation to ensure high-quality.
We have worked on a wide variety of products in the field of haemostasis and coagulation, and we can optimise your design or concept to reach its full potential.
We are ISO 13485:2016 certified and comply with Title 21 of the FDA CFR Part 820, as well as EU IVDR, meeting the top standards in the industry.
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