Search results for “cpsr assessment,”
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Medical Device Label, IFU & UDI Review (FDA)
Medical device labels sold in the US must meet 21 CFR Part 801, and most need a unique device identifier under 21 CFR Part 830. We review your labe...
View full detailsUS Cosmetic Label Review (MoCRA & FDA)
US cosmetic labels must meet FDA's labelling regulations, the Fair Packaging and Labeling Act and MoCRA, which adds a US contact for adverse event ...
View full detailsUS Responsible Person for Cosmetics (12 Months)
Under MoCRA, the responsible person is the company named on a cosmetic's label, with a US address or contact for adverse event reports. Phoenix Saf...
View full detailsMoCRA Product Listing — Volume Plans
Under MoCRA, the responsible person must list each cosmetic product with FDA and update listings every year. We prepare and submit listings in Cosm...
View full detailsEU CPNP Product Notifications for EU Cosmetic Products
A CPNP notification is the pre-market notification of a cosmetic on the Cosmetic Products Notification Portal (CPNP), the European Commission's fre...
View full detailsUK SCPN Product Notification for UK Cosmetic Products
An SCPN notification is the pre-market notification of a cosmetic product on Submit Cosmetic Product Notifications (SCPN), the UK government servic...
View full detailsMoCRA Enterprise Annual Package
MoCRA Enterprise is a 12-month programme for brands with 100 or more SKUs or several facilities. It adds a dedicated regulatory manager, a 1-busine...
View full detailsCosmetic & Fragrance Brand Launch Consultation
A cosmetic brand launch consultation is a guided planning session for founders that sets out, in order, everything a new cosmetic or fragrance bran...
View full detailsRestricted Ingredients Compliance & Validation
A restricted ingredients check is a focused review of named ingredients in a cosmetic formula against the UK and EU lists of banned and restricted ...
View full detailsProduct Information File (PIF) for Beauty Products with Variations
A PIF for product variants is one consolidated Product Information File for several versions of the same cosmetic, such as a lip balm in five shade...
View full detailsMoCRA Small Business Exemption Check
MoCRA exempts some small businesses from facility registration and product listing, based on average annual US sales over three years, but not for ...
View full detailsOTC Drug Facts Label Review (Monograph Conformity)
OTC drugs such as sunscreens, acne treatments and antiperspirants must carry a Drug Facts label in the format set by 21 CFR 201.66, with wording th...
View full detailsSafety Data Sheets for Amazon UK Products
An Amazon UK SDS is a safety data sheet written to Great Britain's chemical rules — UK REACH and GB CLP — for upload in Seller Central once Amazon....
View full detailsAllergen Compliance Check for Cosmetic Products
A fragrance allergen labelling check works out which fragrance allergens in your cosmetic must be named in the ingredient list on your label. Under...
View full detailsProduct Information File (PIF) for Fragrances and Perfumes
A fragrance PIF is the Product Information File for a perfume, eau de parfum, eau de toilette or body mist. Like every cosmetic, a fragrance must h...
View full detailsFDA MoCRA Product Listing for Cosmetic Products
The US Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires each facility that manufactures or processes cosmetics for the US market ...
View full detailsCinnamon Amber Spicy Perfumes Unisex 1155
Quick answer Spicy Cinnamon Amber 1155 is a unisex spiced gourmand perfume oil sold in bulk from 100 g to 5 kg. Bergamot and apple open onto cinna...
View full detailsPowdery Rose Musk Perfume Oil For Women 1116
Quick answer Powdery Rose Musk 1116 is a feminine rose perfume oil sold in bulk from 100 g to 5 kg. Rose and raspberry open onto jasmine and lilac...
View full detailsCrisp Sea Salt Fragrance Oil Unisex 1229
Quick answer Crisp Sea Salt 1229 is a unisex minimalist perfume oil sold in bulk from 100 g to 5 kg. Sea salt and sage open onto ambrette, finishi...
View full detailsOriental Rose Amber Unisex 1226 Perfume Oil Bulk Fragrance Oil
Quick answer Oriental Rose Amber 1226 is a unisex oriental rose perfume oil sold in bulk from 100 g to 5 kg. Bergamot and Amalfi lemon open onto T...
View full detailsClassic Mandarin Rose Women 1214 Perfume Oil Bulk Fragrance Oil
Quick answer Classic Mandarin Rose 1214 is a feminine rose perfume oil sold in bulk from 100 g to 5 kg. Mandarin and bergamot open onto rose, jasm...
View full detailsCrisp Vetiver Grapefruit Men 1202 Perfume Oil
Quick answer Crisp Grapefruit Vetiver 1202 is a masculine fresh perfume oil sold in bulk from 100 g to 5 kg. Grapefruit, bergamot and pineapple op...
View full detailsSweet Gourmand Tuberose Fragrance Oil For Women 1086
Quick answer Sweet Gourmand Tuberose 1086 is a feminine gourmand floral perfume oil sold in bulk from 100 g to 5 kg. Almond, coffee and jasmine op...
View full detailsRich coffee Rose Perfume Oil Unisex 1120
Quick answer Rich Coffee Rose 1120 is a unisex coffee perfume oil sold in bulk from 100 g to 5 kg. Coffee and rose oil open onto vanilla and Amalf...
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