COVID-19 Pandemic Response
Global Regulatory and Quality Support hot line.
We understand you need us to be quick. Contact us and we will get back to you the same day whenever we can to start the conversation.
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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
DNA
RNA
Protein
Cell
Tissue
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