At Hart Biologicals, we design bespoke controls and reagents for use in your diagnostics. Our friendly team consists of multi-skilled experts, able to solve your problems and support you through every stage of your project.
We’ve worked on a wide variety of products in the fields of haemostasis and coagulation, so we understand the products and the market. We’ll work with you to determine a cost-efficient, quality solution, tailored to your specifications and desires.
We also provide bespoke research-use only prototype products available for testing, so we can get instant verification and validation to ensure that we are satisfying our customers’ needs with the final product prototype, saving both time and money.
Our R&D findings are shared with clients in regular meetings and calls to keep you up to date on the prototype progress and product development.
All of our manufacturing takes place at our headquarters in Hartlepool, which gives us complete control over products, processes, and documentation to ensure the highest quality.
Our expertise enables us to provide our contract manufacturing partners with product validation documentation for every stage of the journey, internal regulatory support and clinical validation activity for full life-cycle support from start to completion.
We are backed by a strong regulatory team whose top priority is to ensure compliance to our exact/specific/industry standard.
We are ISO 13485:2016 certified and comply with comply with Title 21 of the FDA CFR Part 820, as well as EU IVDR, meeting the top standards in the industry.
To find out more:
Call us: +44 (0) 1429271100
Email us: admin@hartbio.co.uk
