For biotech leadership teams
The science is documented to a regulator's standard. The operating layer that carries it to market usually is not — it lives in a few people's heads, rebuilt under deadline at every company.
140 readiness items across eight stage gates, from asset selection to first commercial sale. Each item is scored on whether it has an owner, a process, a budget and a system behind it, so a capability that exists on paper but has none of those reads as a gap rather than a tick.
Gaps are prioritized by legal and regulatory exposure, not by lowest score, and weighed against your runway and your next milestone rather than a generic checklist.
A low score becomes an entry in the risk register with a named owner, a due date and a next step. The plan lives in the system, not in one person's head.
Your own team, a vetted vendor, or an expert advisor matched to that specific item.
Twenty-one departments, each scored against the same framework.
Each with an owner and a date. Vendors, CROs and CDMOs are assessed too.
Four items that take longer to close than most teams expect.
| Gap | Department | Typical lead time |
|---|---|---|
| Commercial-scale manufacturing & process validation | Manufacturing & Supply | 18–24 months |
| Serialization & DSCSA trading-partner compliance | Quality / IT | 12–18 months |
| Government pricing & gross-to-net infrastructure | Market Access / Finance | 12–18 months |
| Pharmacovigilance system & safety reporting | Pharmacovigilance | 12–18 months |
Found with two years to run, each of these is a budget line. Found with six months, each is the date.
Illustrative, not company-specific.
A readiness snapshot for one company, then the tracker behind it.
Illustrative only — sample company.
Start with the gates you're in. Items from earlier gates stay in your tracker as you move forward.
Invitation-only access, two-factor login, role-based permissions, and encryption in transit and at rest.
The framework is the enterprise operating plan refined across two biopharma companies through commercial launch and a $1.2B exit.
Request an evaluation: your workspace configured, a two-hour onboarding with your team, and a scored baseline before your next board cycle.