Tech Transfer + Validation Oversight + PPQ & Launch Readiness
Your filing depends on a CDMO you do not control.
Keystone gives emerging biotechs a senior program lead on their side of the table. Someone who has run these programs from inside a CDMO, and knows where they slip before it shows up in your timeline.
CDMO-Side Experience
Built Inside the Plant
Founder Led
Direct Senior Ownership
Remote-First
Onsite When It Matters
Outcome Owned
Measured by Program Results
THE NEED
Small CMC teams carry big programs. Something has to give.
When one or two people own the program your filing depends on, there's little room to challenge a CDMO schedule that keeps moving.
Tech transfer is slipping
Batches are moving right, the CDMO’s schedule keeps changing, and nobody on your side has the time or depth to challenge it.
Problems surface late
Deviations, change controls, and investigations arrive after decisions are already made. You’re reacting to the CDMO instead of steering the program.
The filing is getting closer
PPQ and pre-approval inspection are on the horizon. Leadership, investors, and the board want a straight answer on whether manufacturing will be ready.
THE DIFFERENCE
Most sponsor-side consultants learned CMC from the sponsor’s chair. Keystone learned it inside the CDMO.
That means knowing what a realistic CDMO schedule looks like, which questions surface risk early, where validation and quality documentation fall short, and how to hold a partner accountable without damaging the relationship you depend on.
PROOF
Built Inside the Plant.
Client Product Introductions
Directed multiple concurrent client product introductions at a CDMO, from equipment implementation through process qualification, GMP release, and commercial readiness.
Independent Assessment
Led independent process validation assessments for commercial sites, presenting findings and remediation priorities directly to global quality leadership.
New API Onboarding
Led cleaning validation risk assessments for new client APIs entering a multi-product CDMO facility, setting carryover limits, worst-case strategy, and cleaning verification requirements that determined when each product could run.
Program Governance
Led governance of a $70M+ commercialization program that reached saleable production roughly six weeks ahead of plan.
HOW KEYSTONE WORKS
Clarity first. Then steady ownership.
Assess
Get an independent read on where the program really stands: the plan, the CDMO’s readiness, open quality items, and the realistic path to PPQ and filing.
Align
Set priorities, ownership, and decision points that your team, your CDMO, and your leadership all agree are real.
Lead
Run governance, review what matters, surface risk early, and keep executive reporting honest.
Hand off
Close out cleanly. That could mean a filed program, a stronger internal team, or a smooth transition to a permanent hire.
FIT
Best fit: a sponsor with a program that matters and a team stretched thin.
Keystone works with U.S. biotech and specialty pharma companies, typically Phase 2 through early commercial, that manufacture through one or more CDMOs. It’s not a fit for routine staff augmentation or for sites that need a full-time onsite validation team.