Manufacturing contracts

IVD OEM and services contract

Whether you are a start-up, spin-off, or Biotech with a new IVD business looking for a specialist partner to make your projects happen. Whether you need research and development support, or a manufacturing facility and capacity. ZenTech puts 30 years of In Vitro Diagnosis (IVD) experience at your service!

As an expert in IVD product manufacturing, the ZenTech team’s expertise for various applications are available to you, from component supply to full development of new products.

ZenTech can therefore:

• Produce liquid or lyophilized solutions according to your formulation
• Provide components in bulk format
• Fill containers and ensure their packaging
• Package the finished products such as diagnostic kits
• Produce positive and negative controls for IVD kits (liquid or on paper media)
• Produce components in large quantities on solid media such as microplates, nitrocellulose membranes, etc.
• Validate IVD products using automated ELISA technology, mass spectrometry or molecular biology techniques according to European regulation (98/79/EC)
• For pharmaceutical companies, biotech companies and others, develop and validate new IVD products based on ELISA technology, mass spectrometry, immunochromatography (lateral flow) or molecular biology

These skills acquired through numerous developments have also been strengthened and continually improved through the very strict application of standards and regulations concerning the In Vitro Diagnostics sector, i.e., ISO 9001-2016 – ISO 13485-2015 – EC 98/79 IVD Directive and soon EC 2017/746.

If you are interested in one of our services, or are seeking a collaborator, contact us directly to review your project together.