Exbio — CDMO — About CDMO

CDMO Partner for Diagnostic Reagent Solutions

What we do?

EXBIO supports instrument manufacturers from reagent design through controlled IVD reagent production and technical documentation.
 

Why partner with us?

EXBIO is a reliable and flexible CDMO partner for custom IVD reagent programs, built on quality, regulatory compliance and long-term commitment.
 

EXBIO service offering:

  • Proof of Principle & Reagent Design
  • Product Development for Instrument Platforms
  • Contract Manufacturing
  • IVDR Technical Documentation
  • Conformity Assessment Support
  • EU Market Access Support

Reagent Design & Product Development



We translate your assay and performance requirements into an instrument-specific reagent concept and product development plan — from proof of principle, antibody and fluorochrome selection to finished formulation, pilot batches and design verification and validation activities.

Contract Manufacturing




We provide controlled IVD reagent production, including defined QC testing and batch release in compliance with applicable regulatory requirements.

IVDR Technical Documentation

 


We prepare technical documentation in compliance with applicable IVDR requirements to support conformity assessment, including product specifications, design and development records, performance data and manufacturing information.

Conformity Assessment & EU Market Access Support



We support the IVDR regulatory pathway, including Conformity Assessment, Declaration of Conformity support and EU market access activities, where applicable and within the agreed regulatory roles.