Global Compliance

Global regulatory compliance support.

Tell us the destination market and we will tell you — in writing — what has to be filed, what we prepare, and what stays yours. Ten of those are third-party lab reports published on this site — 7 from GDDCM and 3 from NACC, all issued by CMA- and CNAS-accredited laboratories. The park covers 30,000 m², of which 5,000 m² is the ISO 22716 GMP workshop; 220 people work here, and the monthly capacity is 300,000 bottles.

Send us the destination market and the claims you intend to make, and we tell you in writing what has to be filed, what we prepare, and what stays yours — usually within 48 hours of the brief.

The routes are not interchangeable: FDA for the United States, CPNP for the European Union, APVMA for Australia. A registration in one market is not evidence in another, and we will not present it as such.

Coverage by destination market

Four markets we ship to regularly. Anything else — ask, and we will confirm before you commit.

US

United States

  • FDA establishment registration
  • Cosmetic Good Manufacturing Practice
  • State-level requirements on request
  • CPSC guidance where a product falls in scope

EU

European Union

  • CPNP notification support
  • REACH and BPR documentation
  • Responsible Person coordination
  • EN and 中文 label compliance

AU

Australia & New Zealand

  • APVMA registration support
  • NICCAS / AICIS ingredient disclosure
  • ARTG listing coordination where in scope
  • English-language dossier assembly

Global

Every destination

  • MSDS / SDS in 16 languages
  • SGS and Intertek test coordination
  • Batch-specific COA on every shipment
  • Free Sale Certificate and origin documents

What the service actually covers

Not a certificate wall — the work between your formula and a cleared shipment.

  • Compliance document preparation handled in-house by two regulatory specialists

  • Third-party laboratory coordination — SGS, Intertek, Pony Testing, AMA Labs, Eurofins

  • Dossier assembly in the destination market’s language

  • Ten-year digital archive of every issued document, retrievable per batch

Compliance FAQ

Compliance FAQ

Straight answers. Where the honest answer is a limit, we state the limit.

Do you handle compliance for my destination market?
For the United States, European Union, Australia/New Zealand and the major EAEU and Latin American markets, yes — we prepare the documentation and coordinate third-party testing. For a market we have not shipped to before, tell us the destination and we will confirm in writing what we can and cannot cover before you commit.
Can you provide an MSDS or SDS?
Yes. An SDS in 16 languages ships with every consignment, alongside a batch-specific COA, INCI disclosure, allergen declaration, animal-testing statement and Certificate of Free Sale where applicable. All documents are digitally signed and archived for ten years.
Who has to do the regulatory filing — you or us?
We prepare and assemble everything the destination requires. A market-specific registration still has to be made in your company’s name, because it attaches to your brand rather than to ours. We will tell you exactly which steps are ours and which are yours before the first sample.
What if my product makes a claim we have not tested?
We will say so, and we will tell you what testing would be required to substantiate it. An unsupported claim is a customs and liability risk in every market, and we do not put one on a label. This is the same answer we give in writing during development.

Check compliance for your target market.

Send the destination and the product type. You get a written answer on what is required and who owns each step — before any sample is made.

Check my market

Which route your destination uses

The routes are not interchangeable. A registration in one market is not evidence in another, and we do not present it as such. The last column is deliberately the buyer's side of the line: a factory that claims to handle everything is a factory that is handling something that legally cannot be handled for you.

The regulatory route, the documents we prepare and the documents that stay the buyer's responsibility, for each destination market.
DestinationRouteWe prepareStays yours
United StatesFDA establishment registration
  • Facility registration held and verifiable in the FDA database
  • Cosmetic GMP and batch records, packaged into a dossier
  • MSDS / SDS in 16 languages, shipped with every consignment
  • Your brand registration and listing -- the factory cannot hold it for you
  • A Responsible Person in the US market if the label requires one
  • State-level rules, quoted per destination state
European UnionCPNP notification (Regulation EC 1223/2009)
  • CPNP notification dossier prepared and submitted on your behalf
  • PIF, REACH SVHC and BPR documentation assembled from the actual formula
  • Bilingual EN / Chinese label artwork with the mandated information panel
  • A Responsible Person inside the EU -- legally your company, so we document the handover
  • A signed statement of the claims you intend to make
  • The final artwork approval
United KingdomUKCA -- a separate market from the EU
  • Documentation prepared against UK requirements, not EU ones
  • Test coordination through SGS, Intertek or Pony Testing
  • Free Sale Certificate and origin documents
  • Your UK Responsible Person
  • The importer of record
Australia & New ZealandAPVMA / ARTG, depending on the claim
  • APVMA registration support, scoped to the claim on the label
  • NICCAS / AICIS ingredient disclosure generated from our formula records
  • English-language dossier assembled end to end
  • The therapeutic-goods decision, if the product is in ARTG scope
  • ARTG listing coordination has its own timeline and is scoped separately
Russia & EAEUEAC conformity declaration
  • The largest single destination group we ship to
  • EAC documentation prepared per product
  • Free Sale Certificate and origin documents
  • The importer of record and the declaration holder
BrazilANVISA notification (cosmetics)
  • ANVISA notification route for cosmetics, prepared per product
  • Portuguese label artwork where the claim requires it
  • The Brazilian importer of record
Middle EastGCC market-by-market
  • Documentation prepared per destination, not for the region as a whole
  • MSDS / SDS in 16 languages with every consignment
  • The importer of record in each market

For a market we have not shipped to before, tell us the destination and we will confirm in writing what we can and cannot cover before you commit.