How do you support FDA and US market compliance?

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Accepted Answer

For the US market we supply the ingredient documentation and batch records needed under FDA cosmetics rules (MoCRA) and, where applicable, the FD&C Act. RequirementSupport ProvidedMoCRAFacility and product information support, ingredient identity and batch COALabelingINCI (Gardenia jasminoides Flower Water), finished-product labeling dataImportDocumentation for FDA/US CBP clearance of the raw materialGood manufacturingProcess description and hygiene controls aligned with cosmetics GMPUnder MoCRA, finished cosmetic products must be registered and their facilities listed, and serious adverse events reported — responsibilities that rest with the US responsible person, i.e., your company or your customer. We act as the upstream documentation partner and can coordinate with your US compliance vendor.Tell us your US filing structure and we will provide the requested documentation package.

Requirement	Support Provided
MoCRA	Facility and product information support, ingredient identity and batch COA
Labeling	INCI (Gardenia jasminoides Flower Water), finished-product labeling data
Import	Documentation for FDA/US CBP clearance of the raw material
Good manufacturing	Process description and hygiene controls aligned with cosmetics GMP

How do you support FDA and US market compliance?

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