Diagnostics and IVDs

We have the track record in IVDs that is second to none. Whether it’s a multi-gene assay from a next-gen sequencer, a companion diagnostic, artificial intelligence for automated pathology image analysis, traditional laboratory ELISA or Point of Care rapid tests, we have the global experience to support you.

  • Artificial Intelligence

  • Companion diagnostics

  • Genomics and proteomics

  • Home use tests

  • Molecular diagnostics

  • Laboratory tests

  • Point of care rapid tests

  • Software as medical device

Comprehensive Diagnostic Capabilities with all Types of Biomarkers











Our response to COVID-19

Our team is ideally suited to support Emergency Use Applications at a global scale. We are up to speed in a fast-moving world: through detailed, current understanding of emergency regulatory processes, backed by strong relationships and expertise built over decades.

We support clients through a streamlined, staged process:

Express, objective review of your product and its international regulatory status and evidence base

Assessment of optimal pathway – including optimal positioning and eligibility for expedited processing or exemption

Rapid applications to regulators

Real time support to expedited regulatory reviews with fast global communications in any time zone

Let Us Know What You Think

If you've got any questions or would just like to learn more about what how we could work together, then get in touch.