Start with a bounded, fixed-fee assessment, scale into ongoing oversight when you're ready, and engage embedded leadership only if you need it. Every model leaves the roadmap and records in your hands — whichever track fits your program.
Book a callWhatever seat you sit in, every engagement follows the same deliberately low-risk arc. Most start at Step 1, where the risk is lowest: if the assessment finds you in good shape, we will say so — and the roadmap is still yours.
Your program, your operation, or your AI exposure — honestly mapped, with a graded roadmap you own outright. Valuable whoever executes it.
3–4 weeks · fixed fee
A signal framework, a protocol review, a governed AI pilot, a credentialed pod — one fixed scope, one measured outcome, before anything scales.
Fixed scope · fixed fee
Named reviewers, embedded counsel, or an enablement retainer — running alongside your work, scaled to activity, documented by default.
Ongoing · retainer
Built for
Not the right fit if
However you start above, the commercial mechanics come down to two flexible structures — an ongoing retainer or a fixed-fee project — each delivered directly by the named principals.
Continuous strategic partnership and on-demand access to our founders.
Guaranteed, priority access to our founders for ongoing strategic guidance. Ideal for high-level decision support, ad-hoc "red team" reviews, and serving as an objective expert on your advisory board.
Our founders embed within your organization as your fractional C-level resource (e.g., Fractional Chief Medical Officer, CTO, or CSO). Includes hands-on team leadership, operational oversight, and direct management of strategic initiatives.
Explore the roles: Fractional CMO · Fractional CTO
Transparent, predictable pricing for discrete, high-impact deliverables.
Pre-scoped engagements with defined timelines, deliverables, and pricing. No open-ended retainers, no scope creep—just decisive outcomes at critical decision points.
Custom Engagements: Need something outside our standard packages? We can scope custom fixed-fee engagements tailored to your unique requirements.
Not sure which model fits your needs?
Book a Strategy CallTransparent pricing, predictable timelines, and high-impact deliverables. Each package is designed to de-risk your program at critical decision points.
Comprehensive risk assessment of your regulatory submission before filing. Identify gaps, strengthen your CMC story, and anticipate agency questions.
Key Deliverable:
50-page risk assessment report + 2-hour founder-led debrief call
End-to-end protocol design for advanced therapies including dose-escalation strategy, patient selection criteria, and regulatory-grade endpoints.
Key Deliverable:
Optimized protocol + global health authority (GHA) strategy memo
FDA/EMA/PMDA meeting preparation package including briefing books, anticipated questions, and regulatory positioning strategy for Type B, Type C, or pre-IND meetings.
Key Deliverable:
FDA/EMA/PMDA meeting prep package with Q&A scenarios
Comprehensive pharmacovigilance system audit to identify compliance gaps, SOPs weaknesses, and inspection-readiness across signal detection, case processing, and QPPV oversight.
Key Deliverable:
PV system gap analysis + prioritized remediation plan
Vendor-agnostic assessment of your AI/ML readiness including data governance, model validation frameworks, and regulatory positioning for algorithm-driven endpoints.
Key Deliverable:
Vendor-agnostic AI roadmap + RFP template for vendor selection
Independent "fit-gap" analysis of clinical trial management systems, EDC platforms, or safety databases to ensure regulatory compliance and operational efficiency.
Key Deliverable:
Fit-gap analysis + vendor scorecard with implementation risk assessment
Post-acquisition technology integration playbook for clinical operations, including data migration strategy, system consolidation roadmap, and Day 1/100 deliverables.
Key Deliverable:
100-day technology integration playbook with prioritized action plan
Build a working Retrieval-Augmented Generation (RAG) prototype to answer questions from your document library (protocols, SOPs, regulatory submissions) with full source traceability.
Key Deliverable:
Custom RAG tool for your document library + governance framework
The ultimate pre-launch or pre-Series A audit. Both founders conduct a comprehensive end-to-end assessment of your program covering clinical strategy, regulatory positioning, technology infrastructure, partner readiness, and fundraising positioning.
Key Deliverable:
100+ page board-ready report + 30-day prioritized action plan across clinical, regulatory, technology, and partner domains
Every engagement ends with deliverables you own outright — not a retainer dependency. The names change by track; the standard doesn't.
3–4 weeks · fixed fee · yours to keep
Fixed scope · fixed fee · yours to keep
Ongoing · retainer, scaled to activity
Ready to start? Scope your first engagement on one call — no commitment required.