Diagnostic tests development

Your partner from product development to regulatory compliance

We can bring your research to application. We leverage our development and industrialization resources and talents to turn your idea into a successful product. This service also applies to diagnostic tests that already exist but that can be improved to increase performance, for example by adopting automated and high-throughput platforms or combining the detection of several analytes. Validation of assay performance and regulatory support for commercialization purposes can be provided as well.

Custom antibodies and proteins

Our goal is to provide a flexible antibody and protein service program tailored to your needs

Our clients are research laboratories and institutions and commercial companies. The final goal is the same: a fast track for your scientific discoveries. DIATHEVA is the resourceful partner that makes you fill the gap between your application and the lack of research tools for it. We offer you a fast and cost-efficient customised production without compromising on top quality and high lot-to-lot reproducibility.

Custom monoclonal antibody production services

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Custom polyclonal antibody production services

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Custom recombinant protein production services

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Custom antibodies and proteins

Our goal is to provide a flexible antibody and protein service program tailored to your needs

Our clients are research laboratories and institutions and commercial companies. The final goal is the same: a fast track for your scientific discoveries. DIATHEVA is the resourceful partner that makes you fill the gap between your application and the lack of research tools for it. We offer you a fast and cost-efficient customised production without compromising on top quality and high lot-to-lot reproducibility.

Custom monoclonal antibody production services

read more

Custom polyclonal antibody production services

read more

Custom recombinant protein production services

read more

Kit development

Custom R&D and manufacturing of diagnostic kits – we make it your way

Diatheva has invested resources for the creation of new laboratory tests and for the continuous improvement of our products in collaboration with strategic synergies and many partners. In close collaboration with our customers, we identify the ideal product concept and develop it into a market-ready product according to specific requirements, establishing a robust and reproducible manufacturing process for your product. We offer quality, consistency and validation activities following international standards.

Design and feasibility study

Development and Validation

Manufacturing

Compliance

Kit development

Custom R&D and manufacturing of diagnostic kits – we make it your way

Diatheva has invested resources for the creation of new laboratory tests and for the continuous improvement of our products in collaboration with strategic synergies and many partners. In close collaboration with our customers, we identify the ideal product concept and develop it into a market-ready product according to specific requirements, establishing a robust and reproducible manufacturing process for your product. We offer quality, consistency and validation activities following international standards.

Design and feasibility study

Development and Validation

Manufacturing

Compliance

Regulatory support

We will guide you through the regulatory maze to commercialize your diagnostic test

We assist you in the design and preparation of the technical files necessary to submit the application for CE Marking In Vitro Diagnostic (IVD) which is required for all diagnostics tests before commercialization. Also, we can facilitate the regulatory submission for your products that are already CE-IVD certified, which will need to be updated according to the new normative IVDR 2017/746, coming into force in 2022.

Regulatory support

We will guide you through the regulatory maze to commercialize your diagnostic test

We assist you in the design and preparation of the technical files necessary to submit the application for CE Marking In Vitro Diagnostic (IVD) which is required for all diagnostics tests before commercialization. Also, we can facilitate the regulatory submission for your products that are already CE-IVD certified, which will need to be updated according to the new normative IVDR 2017/746, coming into force in 2022.

Want to become our OEM partner? We will work in close collaboration with you to design, assemble and provide custom products tailored to your specifications and that will meet your quality expectations.

Contact us

Find out what we can do for you!