Search results for “responsible person”

MoCRA requires the responsible person to keep records showing adequate safety substantiation for each cosmetic sold in the US. FDA does not prescri...

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...

Foreign cosmetic facilities must register with the FDA under MoCRA and name a US agent. This package covers both: we prepare and submit your regist...

Medical device establishments selling in the US must register with FDA every year and list their devices. We prepare and submit registration and li...

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 ...

Before selling a medical device in the US you need to know its FDA class and whether it needs a 510(k), is exempt, or needs another route. We resea...

MoCRA exempts some small businesses from facility registration and product listing, based on average annual US sales over three years, but not for ...

Each OTC drug sold in the US, such as a sunscreen or acne treatment, must be listed with FDA and carry a National Drug Code. We prepare the drug li...

Sunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them mu...

Under MoCRA, every facility that manufactures or processes cosmetics for US distribution must register with the FDA and renew every two years. We p...

A cosmetic formulation review is an early-stage diagnostic check of a draft or existing formula. It tests whether every ingredient is permitted, us...

MoCRA requires cosmetic facility registrations to be renewed with the FDA every two years. We check your existing registration in Cosmetics Direct,...

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...

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...

Formulation compliance validation is the final compliance sign-off of a finished cosmetic formula, carried out just before the Cosmetic Product Saf...

A cosmetic packaging compatibility assessment evaluates whether your formula and its packaging are compatible: that the product will not react with...

A Poison Centre Notification (PCN) is the submission that EU/EEA importers and downstream users must make before placing on the market a mixture cl...

Quick answer Fresh Pineapple Musk 1200 is a masculine fruity perfume oil sold in bulk from 100 g to 5 kg. Pineapple, blackcurrant, apple and berga...

A cosmetic brand launch consultation is a guided planning session for founders that sets out, in order, everything a new cosmetic or fragrance bran...

Quick answer Caramel Vanilla 1015 is a unisex oriental gourmand perfume oil sold in bulk from 100 g to 5 kg. Lemon and bergamot open onto caramel,...

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...

Quick answer Sweet Fruity Floral 1177 is a unisex citrus floral perfume oil sold in bulk from 100 g to 5 kg. Sicilian orange and bergamot open ont...

Quick answer Fruity Berry Amber 1148 is a feminine fruity perfume oil sold in bulk from 100 g to 5 kg. Raspberry, strawberry and mandarin open ont...