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Researcher

We combine senior domain experts into bespoke teams to solve complex product and transaction challenges

Growth Strategy & Commercial Acceleration

  • Strategic advisory for scaling, partnerships & new market entry​

  • Market sizing & segmentation, competitive analysis & pricing strategy

  • KOL engagement, channel design, sales enablement & 90-day GTM planning

  • Example Deliverables: TAM/SAM/SOM snapshot, competitive matrix, pricing framework, KOL plan, GTM plan & sales materials

Colleagues Working Together
Laboratory

Regulatory Strategy & Submissions

  • Global regulatory: FDA (510(k), De Novo, PMA), EU MDR, UK MHRA

  • CLIA/CAP/NY/California compliance & LDT oversight

  • Pre-Subs, clinical study design & regulatory pathway planning

  • Submission authoring, regulatory readiness & risk/gap assessments

  • Example Deliverables: Regulatory strategy memo, gap assessment, Pre-Sub package, submission plan & reviewer Q&A prep

Diagnostics & Lab Operations

  • Assay validation planning, CLIA/CAP/NY/California readiness & quality systems

  • SOP development, vendor/supply chain qualification & operational scale-up planning

  • Throughput modeling, cost modeling & workflow optimization

  • Variant curation, test development & clinical test sign-out

  • Example Deliverables: Lab Director oversight, validation plan template, CLIA/CAP readiness checklist, SOP set (index + samples), vendor risk matrix & throughput/cost model

Lab Worker
Writing on a Clipboard.avif

At-Home Testing & Digital Health

  • Kit & packaging requirements, remote sample collection validation & logistics partners

  • UX content for patient-led testing, telehealth integration & digital reporting workflows

  • DTC strategy, consumer workflow design, compliance oversight, & product/consumer experience

  • Example Deliverables: Kit requirements doc, pre-analytic risk mitigation plan, logistics RFP, UX copy deck & telehealth workflow map

M&A Due Diligence & Investor Advisory

  • Buy-side & sell-side technical diligence

  • Red-flag assessments & valuation support

  • Integration planning & investor memo development

  • Example Deliverables: Diligence checklist, red-flag report, risk scoring heatmap, integration roadmap & investment memo highlights

Image by Gabrielle Henderson
Hospital Cafeteria

Training, Workshop, & Startup Acceleration

  • Payer evidence sprints & regulatory bootcamps

  • CLIA/CAP readiness training

  • Example Deliverables: Pitch decks, executive workshops, workshop agendas, training decks & action plans with owners & timelines

Executive Leadership

  • Find fractional/full-time CEOs, COOs, CMOs, CSOs, CCOs, Lab Directors & other executive leaders​ for role placement

  • Oversight of company-wide operations, cross-functional execution & organizational alignment

  • Process optimization, infrastructure scaling & operational readiness for growth

  • Deliverables: Company-wide operations assessment & prioritized action roadmap, process optimization recommendations & implementation tracker

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SERVICE PACKAGING

Pricing

Expert Deep Dive (2 hours + memo)

4-week Sprint (playbook + roadmap)

Diligence Package (scope-based)

Retainer Advisory (monthly)

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