Comprehensive services to accelerate your co-development processes
As individualized medicines and targeted therapeutics become increasingly prevalent, so does the need for rapid innovation in companion diagnostic (CDx) and biomarker development. Our understanding of regulatory expectations for companion diagnostics enables our team to work seamlessly with pharmaceutical and diagnostic providers to integrate all aspects of CDx co-development processes and to drive towards contemporaneous approvals.
Beaufort’s regulatory experience, combined with our on-going interactions with regulators, is what sets us apart from other CROs. From concept to market, we partner with you to develop a highly tailored and adaptable companion diagnostic development program.
Specialized Areas of Experience
Our project work has included multiple targets, indications, and patient populations including oncology and gene therapy, small molecule and biologics, rare disease, “specific” and “systemic”, adult and pediatric. Programs traverse the co-development process from feasibility to regulatory submission (e.g. clinical, pre-market, and post-market), in the US, Europe, and Asia-Pacific countries. We have also worked with LDT/CTA and final device.
We tailor our services to develop and support a suitable strategy that reflects your needs, the project development phase and the specific country requirements.
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Targets
Targets
- Small molecules
- Biologics – e.g., gene therapies
- Tissue
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Technologies
Technologies
- Immunoassay (TAb, NAb, etc.)
- Immunohistochemistry (IHC)
- Cell-based assays
- Next-generation sequencing (NGS)
- Mass spectrometry
- Liquid biopsy systems- circulating tumor cells (CTC)/circulating DNA
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Therapeutic Areas
Therapeutic Areas
- Oncology
- Immune disorders
- Hematological disorders
Understanding the evolving global regulatory landscape
CDx regulations are constantly evolving, making it challenging to keep up with increasing compliance demands. Our experts understand the necessity of timely regulatory intelligence, and are adept at navigating the ever-changing complexities associated with global regulatory frameworks around drug and diagnostic co-development. We will align your development efforts with regulatory expectations in the U.S., European Union, and Asia Pacific region.
