Our Consulting Journey

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Streamlined an early-phase oncology spinout’s IND-enabling workflow, reducing time-to-submission by 40% and improving FDA alignment through biomarker-driven study design.

Designed a dual-AAV preclinical plan and biomarker roadmap that supported seamless IND preparation for a gene therapy startup.

Converted exploratory mouse model data into a GLP-aware regulatory study package adopted by a partnering CRO.