Operations consulting for OTC and personal care manufacturers.
OTC drugs, cosmetics and personal care sit under FDA rules that punish weak execution. Claraxis helps manufacturers run cleaner, more reliable operations and stay ready for inspection.
The problem
Where OTC and personal care plants struggle
Microbial control
Microbial contamination was the top cause of OTC and personal care recalls in the last 12 months (19 of 54 recall events).
Procedures and investigations
The most-cited drug-plant 483 observations: procedures not written or followed (21 CFR 211.22(d)) and weak investigations (211.192).
Scale-up and change
New products, packaging changes and supplier switches that strain validation and change control.
How Claraxis helps
What Claraxis helps with
- Floor-level cGMP execution and procedure adherence
- Investigations, root cause and CAPA that close
- Purified water and critical utility control
- Equipment and utility validation for new lines and products
- Raw material and packaging supply continuity
- Inspection readiness and hosting
- Primary site FDA contact; hosted FDA inspections and quality audits.
- Led a USP purified water system modernization and built an operational dashboard.
- Plant Manager of a global R&D pilot manufacturing center (2021–2025), supporting 350+ scientists.
- Procurement for raw materials and packaging: supplier negotiation, dual sourcing, recyclable resin qualification.
Roles held before founding Claraxis Group.
Questions
Do you work with cosmetics as well as OTC drugs?
Yes. Claraxis works with OTC drug, cosmetic, personal care and household products manufacturers, where the operational disciplines overlap heavily.
Is this regulatory consulting?
Claraxis provides operational support: how the plant runs day to day. It does not replace your quality unit's responsibilities or regulatory counsel.
Where do the FDA figures come from?
From FDA's public recall and inspection data, tracked live on Claraxis FDA Watch. Figures cover the 12 months to October 2, 2026.
Related
Start with the real challenge.
A 30-minute call, then a written scope before any commitment. Kobe replies personally within one business day.