• A combined 150+ years of lateral flow manufacturing know-how and experience
  • State-of-the-art, high-volume automated production lines across multiple sites
  • Dedicated project management and procurement
  • Established international supply chains
  • ISO 13485:2016, ISO 9001:2015
  • Compliant to FDA 21 CFR 820 and GMP
  • Meet regulatory requirements of UK MDR 2002, IVDD, and IVDR
  • Establishment registration with the FDA.
  • Flexible, international shipping solutions 
  • Commercial and regulatory support
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DI9A7037 – Card & Strip


Scalable solutions to meet growth forecasts while offering contingencies to cope with spikes in demand  


Batches produced on-time and in-full via established procurement, project management and manufacturing processes


Knowledgeable global logistics team that work with our clients’ assembly partners wherever they are 

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Click this link for details of our full lateral flow manufacturing service