Comprehensive services to accelerate your co-development processes
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.
- Small molecules
- Biologics – e.g., gene therapies
- Immunoassay (TAb, NAb, etc.)
- Immunohistochemistry (IHC)
- Cell-based assays
- Next-generation sequencing (NGS)
- Mass spectrometry
- Liquid biopsy systems- circulating tumor cells (CTC)/circulating DNA
- 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.