Fractional leadership
A named senior operator in your Regulatory, Quality, CMC or Clinical seat one to three days a week.
Commercial structure
How we work
Four ways to bring us in, one named lead on every engagement, and a scope agreed in writing before it is priced.
Engagement models
Four ways to engage us
Defined-scope project
Fixed deliverable and fixed date — scoped in writing before it is priced.
Embedded team
Consultants working within your environment for the length of a programme.
Independent review
Audits, diligence and second opinions where having no stake in the outcome is the value.
Every engagement names the individual doing the work before you sign. If that person changes, you approve the replacement.
Predictable, itemised invoicing
How pricing and invoicing work
Time and materials work is invoiced monthly with detail by person, programme and task. Work trending over estimate is flagged when noticed, not when an invoice arrives. Pass-throughs are invoiced at cost, with supporting documentation attached.
What that means
Scope before price. An early warning, not a late surprise. Nothing marked up. Records structured and portable from day one.
The arc of a programme
Where you are determines what a first conversation looks like
01
Concept & feasibility
Pathway and classification analysis, product profile definition and a go/no-go recommendation.
02
Nonclinical & CMC
Phase-appropriate CMC plans, toxicology strategy, CDMO qualification and clinical supply.
03
IND / IDE & first-in-human
Submission assembly, protocol, sites, CRO and safety function before first dose.
04
Clinical development
Phase 2 and 3 delivery, risk-based oversight, data governance and agency meetings.
05
Submission, launch & lifecycle
NDA, BLA, PMA or 510(k) support through review and post-market follow-up.