Our work supports the progression of assets from discovery through IND-enabling readiness.

We provide end-to-end guidance for advancing assets from discovery through IND-enabling readiness. Our support blends scientific depth with program leadership and technical execution.

Process & Analytical Development Strategy
Development of upstream/downstream process strategies and analytical method roadmaps. We assess maturity, identify gaps, define assay readiness, and support technical planning required for scale-up and regulatory compliance.

CMC Program Leadership
Hands-on leadership and advisory across CMC workstreams, including milestone definition, scenario planning, risk mitigation, and integrated decision-making. We help teams maintain clarity, alignment, and on-time progression toward IND or clinical supply.

Manufacturing Scale-Up & Tech Transfer
Support for CDMO/CRO selection, vendor diligence, and operational oversight. We manage tech transfer planning, troubleshooting, and interface coordination to ensure reproducible and compliant manufacturing scale-up.

Regulatory Documentation for IND/Clinical Trials
Preparation and refinement of CMC sections, quality documentation, and supporting technical narrative for regulatory submissions. We ensure alignment between development strategy, experimental evidence, and regulatory expectations.

Early Preclinical & Translational Strategy
Design and evaluation of in vivo/in vitro experiment sets, proof-of-concept plans, and platform activation strategies. We help clients generate data packages that de-risk mechanisms, validate feasibility, and prepare for regulatory engagement.