Search results for “responsible person's”

Under MoCRA, the responsible person must report serious adverse events from US cosmetic use to FDA within 15 business days and keep records for 6 y...

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

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...

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...

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...

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

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...

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,...

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

An Amazon USA SDS is an American-format safety data sheet that follows the US OSHA Hazard Communication Standard (HazCom, 29 CFR 1910.1200), used t...

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 Sweet Gourmand Rum 1140 is a unisex boozy gourmand perfume oil sold in bulk from 100 g to 5 kg. Rum and chocolate open onto coffee an...

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...

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