Compliance & Quality

Compliance is a chain: who is responsible for what, and which document covers which market.

ISO 9001:2015749435 · valid to 2027-08-17
CGMP-ASEAN912/GCN-QLD · Vietnam MoH
US FDAfacility registration FEI 3030839348
ISO 9001:2015 749435CGMP-ASEAN 912/GCN-QLDUS FDA facility registration10,000 m² plant15 filling lines300+ staff

01Certificates and credentials

CredentialNumberIssued / ValidScope
ISO 9001:2015749435Issued 2024-08-20 · Valid to 2027-08-17Manufacture and trade of wet cosmetics
CGMP-ASEAN912/GCN-QLDDrug Administration of Vietnam · 2023-12-06 · 3 yearsASEAN Cosmetic GMP compliance
US FDA facility registrationFEI 3030839348Renewed every two years per FDA rulesRegistration of a cosmetics manufacturing facility

US FDA facility registration is a filing under MoCRA, not an approval or certification. The FDA does not issue a certificate for it.

02Quality system

StageDetails
Incoming materialsMaterials checked against specification and logged.
ProductionBatch record per batch; emulsifying and filling in Class 100,000 cleanrooms.
Finished-product releaseMicrobiological, stability and compatibility testing before release.

03Responsibility split

ItemFactoryBrand
FormulationManufactured to your formula / developed on requestProvides or confirms the direction
PackagingSourced if requiredProvides or confirms specifications
Production & batch records✅—
Finished-product release testing✅—
Market-authorisation documentsAssists with preparation and coordinationFiles as the responsible person
Product Information File (PIF)Provides formula and safety dataEstablishes and holds it
Cosmetic Product Safety Report (CPSR)Provides technical dataCommissions a certified assessor
Label complianceProvides ingredient and net-content dataFinalises per destination-market rules

04Market access

Destination marketMain documentsFactory can provide
European UnionPIF · CPSR · responsible person · CPNP notificationFormula data · GMP and ISO evidence · batch records
United StatesFDA facility registration (factory) · product listing (brand)Facility registration details · FEI number
JapanManufacturing and sales licence · ingredient compliance checkFormula and manufacturing data
AustraliaAICIS declaration · ingredient complianceFormula and manufacturing data
Middle EastCountry-by-country registration and ingredient restriction checksFormula and manufacturing data
ASEANASEAN Cosmetic Directive (ACD) notificationCGMP-ASEAN compliance evidence

05Document coordination

We coordinate documents, we do not issue them. Tell us your market and category — we list what applies, who prepares it, and how long it takes.

Talk to Our Team

Send us your brief. We will tell you what is possible.

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