Regulatory approval & adoption

BiomarkerBay unique capabilities

  • Development and production of diagnostic kits 

  • Assistance in the execution of clinical studies for IVD registration

We offer support and consultancy services for the design and the execution of clinical studies to obtain IVD registration of (companion) diagnostics kits, in agreement with European directives and US regulation (also through notified body). 


We provide tailored market searches and long-term assistance in the development and manufacturing of companion diagnostics kits under ISO 13845:2003 validation.

The strong relationship between BiomarkerBay and academic institutes will contribute in improving reliability, give faster answers and lower the costs.

Take away message: BiomarkerBay in a nutshell - download our flyer here.