Senior operations leadership, where you need it.

Three ways Claraxis helps FDA-regulated consumer products manufacturers: steady the plant, get ready before FDA walks in, and take products from pilot to full production.

Book a 30-minute clarity call Take the Operations Score

01 · Interim plant leadership

Steady the plant. Then make it better.

Part-time or interim plant and operations leadership: daily routines, a weekly scorecard and a stronger team, ready for the permanent hire.

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02 · Inspection & USP water readiness

Be ready before FDA walks in.

A floor-level walk-through, purified water review, investigations and CAPA that close, and preparation for inspection day.

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03 · Pilot-to-plant scale-up

From the pilot plant to full production.

One integrated plan for process, equipment, validation, materials and packaging, governed to the launch date.

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36questions across the 11 areas FDA investigators review on a purified water system

New · Self-assessment · $295

Will your water system survive an FDA audit?

The Water System Readiness Assessment gives you a 0–100 score, a section-by-section gap report with FDA observation risk flags, your top 5 findings and prioritized next steps, instantly.

Take the Water System Audit

Who we help

Built for regulated consumer products.

Ways to work together

Right-sized for the challenge.

Focused ReviewFind the root issues. Leave with a sequenced 90-day plan, owners and measures.Start here Fractional or InterimA senior operator inside your leadership rhythm, with a weekly scorecard.Ongoing Defined ProjectOne milestone you can’t afford to miss: a scale-up, launch or capital project.Milestone

Every engagement starts with a short call, then a written scope before any commitment. NDA signed before any data is shared.

Not sure which fits?

Tell Kobe what’s happening. He replies personally within one business day.

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