Greece & EU · Selling into the US · Prices in euros
Made in Greece. Ready for the FDA.
We help Greek and EU makers of cosmetics, personal care and OTC products get their plants and quality systems ready for the US FDA, and plan the US launch. Your EU compliance stays with your team. We bring the US side.
Chapter 1 · The moment
The US market is open to Greek products. The FDA decides who gets in.
Tariffs already raise the cost of every shipment. A failed inspection or a recall costs far more, and most of what the FDA cites is an execution problem on the plant floor.
- Selling cosmetics and OTC products in the USOTC drugs must be made under FDA cGMP. Cosmetics now fall under MoCRA, which brings FDA facility registration, product listing and safety requirements.
- Building plants that will supply the USA line that will ship to the US must be ready for an FDA inspection. Scale-up, validation and the water system are where dates slip.
Chapter 2 · What we cover
We bring the US side. Your EU team keeps the rest.
Our experience is in US FDA-regulated manufacturing. We work alongside your EU regulatory team, not instead of it.
- We cover: FDA cGMP and inspection readinessHow your plant, procedures, investigations and records would look to an FDA investigator, and the fixes that close the gaps.
- We cover: USP purified water and validationWater systems held to USP requirements, and the full validation lifecycle (DQ, FAT, SAT, IQ, OQ, PQ) for equipment, utilities and processes.
- We cover: scale-up and US go-to-marketPilot-to-production scale-up, and launch plans across US retail, club and e-commerce channels.
- Not ours: EU rules and US filingsEU GMP, the EU Cosmetics Regulation and their responsible people stay with your EU team. FDA registration, listing and label filings are done by specialists; we flag what’s needed and work alongside them.
Chapter 3 · Start small
Two fixed-fee checks. €295 each.
Send us what you have. You get written findings ranked by risk, a short call to walk through them, and a clear next step.
Request a check- US Export Readiness Check · €295For cosmetics, personal care and OTC makers planning US sales: how your plant, procedures and quality records stand against FDA cGMP expectations, and what to fix first.
- Water System Audit · €295Your purified water system’s design, sampling, trends and limits, reviewed against USP requirements the way an FDA investigator would, with the fixes ranked.
Chapter 4 · Then go further
When the check shows real work, we stay and do it.
Scope and price are agreed after the check, once we both know what the work is.
- US Market Readiness ReviewAbout four weeks. A full review of your plant and quality system against FDA cGMP expectations, and a 90-day US launch plan across retail, club and e-commerce.
- Fractional US Launch LeadA senior operator a few days a week who runs the launch: one plan, one date and one weekly scorecard across supply, channel and marketing.
- FDA Inspection Readiness LeadFor plants that will supply the US: scale-up, equipment and utility validation, USP water, and a practice inspection before the real one.
Chapter 5 · Why us
We’ve stood in the room when the FDA arrives.
After 19 years at a global consumer products company, Kobe ran its US pilot plant as primary FDA contact, supporting more than 350 scientists, and closed all observations with zero major findings.
See the projectsOperating roles at a global consumer products company
Start with one check. Decide after.
€295, written findings, no obligation. Remote first, on site when it matters.