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...

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...

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

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...

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 ...

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...

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...

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...

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

Under MoCRA, the responsible person must list each cosmetic product with FDA and update listings every year. We prepare and submit listings in Cosm...

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

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

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

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

MoCRA Essentials is a 12-month package for non-US cosmetic brands. It covers FDA facility registration and renewal management, Phoenix Safety Consu...

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,...

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 Powdery Rose Amber 1230 is a feminine soft rose perfume oil sold in bulk from 100 g to 5 kg. Bergamot and mandarin open onto rose and...

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...

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 ...

Quick answer Fresh Iris Rosemary 1251 is a masculine aromatic woody perfume supplied ready-mixed for self-filling, in a 5 ml sample, 500 ml and 10...

Quick answer Classic Lavender Vanilla 1122 is a feminine lavender perfume oil sold in bulk from 100 g to 5 kg. Bergamot and lavender open onto iri...