For Brands · For ingredient makers日本語

Your data is good. It is written for the wrong room.

You have the test data. I write the English evidence file your overseas buyer's regulatory team will accept.

English evidence dossiers for Japanese ingredient makers and university spin-outs, written by a cell biologist who reads what a brand customer in New York, London or Berlin will be allowed to say with your data.

Amisha · MEng Biomedical Engineering, University of Tokyo · cell biologist · Osaka

A microscope under bench light, a hand adjusting the slide
Bench light, not studio light

The gap

“The data is solid. The English does not exist yet. The first overseas customer asked for a data sheet last month.”

I heard that sentence at booth after booth this autumn. A Japanese technical PDF run through a translator does not become an English evidence document. The order is different, the tiers of evidence are different, and the words that are safe in a Japanese catalogue (浸透, 再生, 幹細胞由来) are the words that stop a review abroad.

The origin gate

Before any claim is read, one question decides which doors are open: what is the material derived from?

Table of four material origins against four markets, each cell a door: open, open with conditions, or closed
Figure 1 · the same study lands differently in each column

Human-derived

Stem cell conditioned media, human exosomes, human cell extracts.

Not permitted in cosmetics in the EU (Annex II, entry 416); most of ASEAN and China draw the same line. Permitted in Korea, but the word “exosome” is banned from cosmetic advertising since January 2025. No origin ban in the US, but “stem cell” and “exosome” language is under active scrutiny and a class action over an exosome serum was filed in June 2026.

Plant-derived

Ginseng, centella, citrus, rice and other plant vesicles and extracts.

Walks through the doors human-derived material cannot. The safety file still has to be built, and the efficacy evidence is thinner than the marketing, which is exactly what a good dossier says out loud.

Milk and microbial

Whey vesicles, lactic-acid bacteria vesicles, fermentation-derived actives.

Same regulatory advantage as plant-derived, with fermentation as a story Japan already tells well abroad. Count, purity and batch consistency are the questions a buyer will ask.

“Exosome-like”

Lysates, mimetics, conditioned media sold under the vesicle name.

The field's own standard (MISEV2023) asks for size, count by two methods, markers and purity before the word is used. Without that, the honest word is “extract”, and the dossier says so.

If you are human-derived, the dossier says so plainly and builds the story that still works. If you are not, that is the first sentence of your English materials, and almost nobody is saying it.

What you receive

One ingredient in. Four documents out, written for the buyer's regulatory team.

Four document mock-ups: a two-page technical data sheet, a six to ten page evidence narrative, a one-table claims-by-market sheet, and a ranked list of gaps
Figure 2 · the English Evidence Dossier
  1. A two-page technical data sheet your sales team sends.Written for a buyer's regulatory team, not a translator: origin, process, what is measured per batch, and the claims your data carries.
  2. A six-to-ten-page evidence narrative your customer keeps.Each study you hold, described and graded: human, reconstructed skin, in vitro, company claim. Nothing promoted, nothing hidden.
  3. What a brand can say with it, by market.The US, EU and Japanese sentence for each claim, in words they can use, and the sentence they should never write.
  4. The gaps worth testing next.Ranked by what each small study would unlock. Often it is one study, and it is not the one you expected.
  • Within one weekA first read of your materials.What the dossier would say, which of the three questions your data already answers, and what I need from you.
  • Every studyGraded, with the label shown.Human, reconstructed skin, in vitro or company data. A buyer sees the label before the number.
  • Every claimThree market sentences and one never-write.US, EU, Japan. The sentence to avoid is written down too, so your sales team does not improvise it.

Three questions every overseas buyer will ask first.

  • Origin. Human, plant, milk, microbe? It decides the countries before it decides the science.
  • Count, in the finished product, by two methods, at month six. Not the supplier's number on the raw material.
  • One human study on intact skin with a vehicle side. No needle, no laser. If the data is post-procedure, the honest claim is a post-procedure claim.

The dossier answers all three where your data allows, and says which one it cannot answer yet.

What it is not

Not an INCI application, not a toxicology dossier, not a registration. I will tell you who does those, and I will have met them.

How it starts

Send your current Japanese materials for one ingredient through the two-minute form, or reply to the email that brought you here. I come back within a week with what I would write and what I would need from you.

Send the materials for one ingredient

You get a first read within the week: what the dossier would say, which of the three questions your data already answers, and what I would need from you to write the rest.

English Evidence Dossier: data sheet plus evidence narrative, US$2,400 per ingredient. Data sheet rewrite only, from your existing Japanese materials: US$900.

Send your materials

I provide scientific communications support: evidence review, claims-language risk flagging, and ingredient rationale writing. I am not a physician, a regulatory professional, or a cosmetic chemist, and I do not conduct clinical testing. I do not do product registration or compliance filings. Final legal and regulatory approval of any claim should remain with your counsel or a qualified regulatory consultant. I work under confidentiality and IP-protection terms as standard.