Companion Diagnostics

Our Companion diagnostics team is focused on the complex issues surrounding Dx-enabled therapies, and drug-diagnostic co-development.

In an era of significant and ever-increasing personalisation of new and on-market therapy assets, ARC Regulatory has the technical expertise and clinical-regulatory know-how to assist both diagnostic and pharma manufacturers to develop and deliver an effective Dx strategy.

We have significant real-time knowledge of the challenges facing both the pharma and diagnostics manufacturers involved in bringing targeted therapies to market. We help joint teams to understand the clinical and regulatory requirements in local and international jurisdictions, including the local regulations for conducting clinical research.

Our expertise

  • ARC Regulatory works with industry leaders to help them align with FDA, and other regulatory body expectations, for their particular assays.
  • Our consultants set up and monitor global central test sites, ensuring CDx clinical performance, data integrity, GCP and local clinical research compliance.
  • ARC Regulatory are leading the way in Dx clinical protocol development, ensuring compliance with new international standards currently in development for IVD clinical performance studies.
  • We offer an unparalleled breadth and depth of experience in this evolving area of the diagnostics industry.
"ARC Regulatory have brought their considerable expertise to our organization in a highly professional way, and have proved invaluable to assigned project teams and functions. Their collaborative integration with our company, combined with detailed knowledge of global requirements and challenges of regulatory and clinical affairs have strengthened QIAGEN’s regulatory and clinical excellence."
Peter Krein, Former Head Clinical Affairs QIAGEN