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Contract Manufacturing at Hart Bio

By Ellie Nixon | 21st February 2024

Contract manufacturing plays an integral part of what we do here at Hart Biologicals. We work with numerous companies globally to help them create and develop products that are suitable for customers specific and defined needs.

What to Expect?

Our solution-driven R&D team, made up of expert scientists, will work with you to help define your problem, find a resolution, and identify your specific project needs. If you have a concept or a fully-fleshed prototype, Hart can help you with your journey. 

Customers can expect the assembly of quality custom products with friendly support through each stage of the project.  

The Journey:

We start with your concept

No matter what stage it is at. Our R&D team are available to work with you to provide full technical, design and development support to produce an innovative reagent or kit that satisfies customer needs.  

This is optimised

As we have worked on a wide variety of products in the field of haemostasis and coagulation, we can optimise your design or concept to reach its full potential.

A prototype is created

Working with both small and large-scale batch sizes, we work efficiently to reduce waste during the production process.

It is manufactured

All our manufacturing takes place at our Hartlepool headquarters. This gives us end-to-end control over products, processes, and documentation, to ensure high-quality.

It is validated

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. We provide our partners with validation documentation for every stage of the journey they take take with us, ensuring quality and reducing time-to-market.

Why Choose Hart?

1. We understand the products and the market

2. We can provide expert advice 

3. We'll work with you to determine a cost-efficient, quality solution

Any customer interested in our service can expect full support from our friendly expert team through all stages of the project.

For more information on Contract Partnerships, click here.

To enquire, click here.