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To find out more about CDx & Biopharma services, enquire now.

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Offering a collaborative CDx partnership approach.

As an established IVD company, Randox offers tailored development and testing solutions to support faster, more effective and safer drug development.

With in-house capabilities, ranging from biomarker selection; manufacturing of bioreagents; production of single and multiplex RUO and IVD grade tests; quality control; provision of clinical laboratory services; regulatory expertise and worldwide distribution we are the partner of choice.

Why Partner with Randox?

Pharmaceutical and biotech companies are increasingly investing in R&D of new therapies to address the growing need for earlier and more effective patient management.

Randox is dedicated to the improvement of personalised, diagnostic, prognostic and predictive assays. Our aim is to help Pharma Biotech and CROs move away from a “one treatment fits all” approach to a personalised medicine approach through the use of companion diagnostics (CDx). At Randox we deliver a fully flexible partnership to accommodate your needs, providing you with tailored protein and molecular assays.

Accreditations

chevron_right ISO13485 Accredited UK Manufacturing Facilities

chevron_right ISO15189 accredited

chevron_right Fully Validated Quality Managment and LMS Systems

chevron_right IVDD 98/79/EC, Currently Transitioning Towards IVDR

chevron_right ISO17043 - Randox International Quality Assessment

chevron_right FDA MDSAP CFR T21 Part 820 Compliant

chevron_right GCP Certified

Randox Biosciences can be your CDx and biomarker assay development partner from early phase trials through to drug launch, addressing all assay requirements in the process, including development of raw materials and assays, verification and validation studies, clinical trial sample analysis, regulatory submissions and co-commercialisation.

Complete CDx Partner Approach

DISCOVERY arrow_forward
Develop critical components & raw materials such as custom antibodies and proteins.
Phase 1 arrow_forward
Develop and manufacture single or multiplex prototype assays.
Phase 2 arrow_forward
Complete verification and validation on locked-down assay
Phase 3 arrow_forward
Full regulatory support including FDA/CE/NMPA.
LAUNCH check_circle
Co-commercialisation of Drug and CDX
RUO & Biomarker Discovery Assays arrow_forward
IUO & CTA Assays arrow_forward
Regulatory submissions arrow_forward
Approved - CDx Assay arrow_forward
Patient sample testing at Randox Clinical Laboratory Services (and/or 3rd party labs if required) arrow_forward

CDx Assay Formats

Randox is focused on advancing precision medicine through high quality, flexible, assay development.  We invite researchers to design custom assays containing multiple biomarkers to ensure maximum output from a limited sample supply. Our proprietary biochip technology can be used in early exploratory biomarker stages through to IVD/CDx grade assays.

CDx Drug and Diagnostic Development Process

local_pharmacy Development of Raw Materials

Extensive portfolio of over 900 products manufactured to ISO13485 standards including mAbs, PAS, HRPs, sdAbs and scFvs.  Custom antibody and protein development is also possible.

local_pharmacy Assay Development

A range of technologies are available including patented biochip technology capable of simultaneously measuring multiple biomarkers from a single sample.  Contract manufacturing capabilities available.

local_pharmacy Sample Testing

ISO15189 accredited laboratories located throughout the UK, Ireland, and USA to meet bespoke sample analysis requirements. Global network of 3rd party laboratories to meet international requirements.

local_pharmacy Verification & Validation

Performance verification and assay validation following CLSI guidelines to ensure all requirements are met.  Regulatory support for submissions and approvals also available.

local_pharmacy Regulatory Submission

Experienced in-house regulatory affairs team provide full regulatory support when preparing IVD/CDx applications. Over 900 licenses globally and 3800 licensed products.

local_pharmacy Commercialisation

Pre and post launch support with laboratory, clinical, patient and KOL engagement.  Strong network of sales and marketing specialists in over 145 countries.