What We Work On
We advise radiopharmaceutical, biotech, and CDMO organizations during critical development, commercialization, and manufacturing transitions.
Our work focuses on ensuring technically sound programs can execute successfully in real operating environments — from planning through clinical and early commercial production.
We’re most often engaged when operational execution is unclear, at risk, or becoming difficult to manage.
I help early-stage healthcare and life science programs translate technical concepts into executable development plans. This includes defining the development pathway, identifying CMC and operational risks, and aligning timelines, regulatory, and manufacturing strategy before costly work begins.
Commercialization and Launch Planning
As programs approach clinical and early commercial stages, operational planning becomes as critical as development.
We help teams align manufacturing strategy, capacity planning, and execution with real-world operational constraints to ensure launch readiness.
I support the transition from R&D or pilot environments into GMP-readu manufacturing. This includes coordinating facliity readiness, equipment implementation, documentation, and operational workflows so programs can enter clinical production without delays.
Tech Transfer and Manufacturing Readiness
Transitioning from R&D into GMP manufacturing introduces complexity many teams underestimate.
We help coordinate facility readiness, documentation, and workflows so programs can enter clinical production without preventable delays.
I advise organizations on CDMO selection, vendor evaluation, and manufacturing sourcing strategy. I help structure realistic partnerships, define scopes of work, and avoid common contracting, capacity, and operational pitfalls.
Program and Development Strategy
Strong science alone is not enough. Programs require a clear operational pathway.
We help define development sequencing, identify manufacturing and CMC risks early, and align technical work with realistic execution timelines.
CDMO and Supply Chain Strategy
External manufacturing partnerships often determine program success.
We support CDMO selection, scope definition, and vendor coordination to ensure partnerships are structured realistically and programs avoid common execution pitfalls.