Senior leadership for your manufacturing program, sized to what you need.
SERVICES
Every engagement is scoped around a defined outcome. That might be an independent assessment, ongoing program leadership, or focused readiness support for the moments that decide a filing.
Your CDMO is running the work. Someone still has to own the program.
Every engagement starts with a defined outcome, clear ownership, and a decision path your team, your CDMO, and your leadership all recognize as real.
The emphasis isn’t on producing more reports. It’s on a program that stays on schedule and a filing that holds up.
01
CDMO Program Assessment
An independent, senior read on where your manufacturing program actually stands. You get a clear diagnosis and a prioritized, realistic path to PPQ and filing.
Typical format: a few weeks, largely remote, fixed fee.
Good for: a new CDMO relationship, a program that feels off the tracks, or leadership that needs a straight answer before a financing or filing decision.
Tech transfer and validation plan review
CDMO readiness assessment
Open deviations and change controls
Risk register review
Realistic timeline to PPQ and filing
Prioritized findings and recommendations
02
Fractional Program Lead
Keystone serves as your senior manufacturing program lead, without a full-time hire. Ownership of the program from your side of the table.
Typical format: monthly retainer with defined program outcome and exit point. Remote-first with planned site visits.
Good for: companies moving through tech transfer and scale-up with a small or stretched CMC team.
CDMO governance and meeting leadership
Schedule and quality accountability
Protocol, report, and deviation review
Change control oversight
Integrated schedule and risk register
Executive and board reporting
03
PPQ & Pre-Approval Inspection Readiness
Focused senior support for the highest stakes window in your program, when PPQ and inspection decide whether your filing holds.
Typical format: fixed scope around your PPQ and filing timeline, including onsite presence at key points.
Good for: companies approaching a BLA or NDA submission
PPQ strategy and protocol review
Campaign oversight
Data and report review
CDMO quality system readiness assessment
Sponsor quality system readiness
Pre-approval inspection preparation
Supporting expertise across every engagement.
Keystone’s technical depth sits underneath all three engagements. It isn’t sold separately, but why it’s the oversight holds up.
Process & cleaning validation
Qualification strategy (ASTM E2500, ISPE C&Q)
Computerized systems and data integrity (GAMP 5, 21 CFR Part 11)
Deviation and CAPA oversight
FDA and EU GMP inspection readiness
Program recovery when a timeline has already slipped