Services

Four service lines. One seat — yours.

Process, change, selection, and oversight — one lifecycle, one advisor, always on the client's side of the table. We don't implement systems and we don't resell software: implementation partners build, and we stay accountable to you through execution.

01 — Process review & optimization

Find what's slowing you down. Fix what matters first.

A full-surface review of how your company actually runs: procurement, inventory and supply chain, contract tracking and vendor management, order-to-cash, planning and reporting, and quality — assessed through four lenses at once.

Operations: where bottlenecks, handoffs, and spreadsheet workarounds are costing you time and money. Regulatory: which processes carry GxP weight — Part 11, Annex 11, data integrity — and, just as important, which don't. Capital: whether your controls, close, and reporting would hold up under a SOX auditor, a PE operating partner, or an IPO process. Global: whether your operating model is ready for the EU expansion everyone knows is coming.

What you receive: a findings report your leadership team can act on, a prioritized roadmap with effort and impact, and quick wins executed inside the engagement. A full assessment typically runs four to eight weeks, fixed fee — and if you're starting smaller, a targeted analysis of one process or one decision takes days, not weeks.

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02 — Change management

Growth generates change faster than most teams can absorb it.

Scaling Life Sciences companies carry three kinds of change at once — regulatory change they must make, growth change they chose, and efficiency change they need. Most teams treat it as one undifferentiated pile, and the urgent crowds out the important.

We categorize the portfolio, plan it against your real capacity, and manage execution until the change sticks: stakeholder and sponsorship mapping, communications, training strategy, integrated scheduling, and adoption measurement.

How we engage: as a defined change program alongside a system or process initiative, or as a standing monthly cadence for companies whose change load has outgrown their bandwidth.

The result: go-lives that don't quietly revert to spreadsheets in month three — adoption that's measured, not assumed.

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03 — System selection

Buy the right system for the company you're becoming.

Selection starts with requirements built from your processes, not a vendor's demo script — then a weighted scorecard across the criteria that matter for the company you're becoming: fit and cost, but also SOX control support, audit trails, IPO-grade close and consolidation, multi-entity multi-currency architecture, and EU statutory readiness. Every recommendation comes with its recorded rationale. We take no vendor commissions, so the scorecard is the whole story.

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04 — Execution oversight

The builder's PM works for the builder. We work for you.

Once you've chosen a system, the implementation partner runs the project — and their project manager answers to their firm's margin, not your outcome. Execution oversight puts an owner in your seat: plan integrity, scope and change-order control, deliverable acceptance, and risk governance, reported to you.

Validation oversight runs through it: the integrator's work arrives inspection-ready — reviewed against acceptance criteria, traceability maintained, data-integrity gates enforced — without gold-plating the parts that don't need it. GAMP 5, FDA CSA, Part 11, Annex 11.

Also engaged mid-flight: if an implementation is already in trouble and no one is on your side of the table, we step into the owner's seat and stabilize it.

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How engagements run

Right-sized, fixed-fee, and fast to start.

The operating model doesn't change between service lines — and it's designed to consume as little of your time as possible.

  • Speed to engage — NDA signable same day. Proposal within five business days of discovery. Verbal yes to signed SOW in ten business days, on plain-language paper. Kickoff inside two weeks.
  • Fixed-fee by default — engagements are scoped around named deliverables and written acceptance criteria. If a phase misses its criteria, we own the gap.
  • Independent, on the record — no software, no build hours, no reseller margin, no referral commissions. Selections are documented decisions that survive scrutiny from your board, your auditor, or your inspector.
  • Also engaged mid-flight — assessments, change programs, and oversight can each start standalone, including on programs already underway.

The people who scope your engagement are the ones who deliver it — senior practitioners with 20–30 years each across GxP operations, SOX/IPO readiness, PE-owned environments, and global deployments, with modern tooling carrying the analytical load.

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