WHO WE SERVE
Built for sponsors who make their product through someone else.
Keystone works with a specific kind of company: one whose most important program runs inside a facility it doesn’t own. The fit question isn’t your therapeutic area. It’s whether you’re accountable for a program you don’t directly control.
Two kinds of companies, one shared problem.
WHO IT’S FOR
01 EMERGING BIOTECH
Clinical-stage, moving toward commercial
Companies moving a biologic or small molecule through tech transfer and scale-up at a CDMO, often with a CMC team of one or two people carrying a program the whole company depends on.
02 SPECIALTY PHARMA
Approaching or entering commercial supply
Companies who products are launching or already in market through contract manufacturers, where launch readiness and supply reliability now carry real revenue risk.
WHERE KEYSTONE IS MOST USEFUL
Moments when a program needs senior ownership.
These are the points where manufacturing program either holds together or starts to slip.
01 A new or changing CDMO relationship
02 A tech transfer that’s behind schedule
03 A Phase 3 start or late-stage financing
04 A filing expected in the next 12-24 months
05 A CMC-related question from the FDA
06 Quality or compliance concerns at your CDMO
NOT THE RIGHT FIT
Keystone isn’t for everyone, and that’s deliberate.
Companies running large in-house manufacturing plants that need full-time onsite validation execution, and routine staff augmentation requests, aren’t a fit. In those cases CQV staffing partner will serve you better. Keystone takes on a limited number of programs so each one gets real senior attention.