OUR SERVICES:
IND ENABLING SUPPORT
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We know your goal is to get to the clinic, and while delivering development candidates is an important milestone, it's not the end of the journey. Efficiently completing the necessary work to successfully file and IND and get regulatory approval to dose your first in human is essential - and we have the know how to help you get there
Our vast expertise in CRO management and specialty in strategy and execution can help you coordinate and successfully complete your IND-enabling activities. We've worked on many project teams and understand the relay race that is getting to the clinic quickly and smoothly. We'll provide the teamwork and capabilities to assist with:
Off-target profiling
Complete developability profiling
CMC readiness
PK/PD & toxicology support
ADA & nAb assay, anti-Id reagent generation
CDMO cell line & process development, phase I supply
Translational strategy & biomarkers integration
Intellectual property filing support
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