Search results for “responsible Person's”

MoCRA requires every cosmetic facility outside the US to name a US agent in its FDA registration. Phoenix Safety Consultants LLC acts as your US ag...

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...

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...

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...

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...

Foreign medical device establishments must name a US agent who lives or has a place of business in the US, under 21 CFR 807.40. Phoenix Safety Cons...

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

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...

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 ...

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...

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

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

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

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...

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,...

Enterprise regulatory compliance consulting helps established and scaling organisations treat regulatory, quality and safety requirements as one st...

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 ...