Search results for “product information file pif”
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EU GPSR Compliance for Menstrual & Intimate Hygiene Products
Quick answer Most menstrual and intimate hygiene products are consumer products under the EU General Product Safety Regulation (EU) 2023/988, whic...
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 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 detailsGPSR Compliance Documentations
The EU General Product Safety Regulation (GPSR, Regulation (EU) 2023/988) applies to consumer products sold in the EU and Northern Ireland that are...
View full detailsStability Testing for EU and UK Cosmetic Compliance
Stability testing shows that your cosmetic stays safe and keeps its intended quality in its final packaging over its shelf life. Under Regulation (...
View full detailsCosmetic Product Formulation Review
A cosmetic formulation review is an early-stage diagnostic check of a draft or existing formula. It tests whether every ingredient is permitted, us...
View full details100 Beauty Formulas Professional Cosmetic Formulation Guide
A recipe says two tablespoons. A formula says 4.5%. That difference is the gap between a hobby and a business, and it is what this book is built on...
View full details30-Minute Expert Consultation for EU, UK and USA Regulations
A cosmetic regulatory consultation is a 30-minute advisory session with a compliance specialist, for brands that need a clear answer on UK, EU or U...
View full detailsFragrance and Cosmetic Products Labelling & Packaging Design
Compliant cosmetic label design is the creation of new label artwork that meets Article 19 of Regulation (EC) No 1223/2009 in the EU and Northern I...
View full detailsBorderline Product Classification
Cosmetic Product Compatibility Assessment
A cosmetic packaging compatibility assessment evaluates whether your formula and its packaging are compatible: that the product will not react with...
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 detailsChildren Product Certificate (CPC)
A Children's Product Certificate (CPC) is a written certificate in which the US importer, or the US manufacturer, of a children's product certifies...
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 detailsToxicological Risk Assessment (TRA) for Beauty Products
A toxicological risk assessment for cosmetics (TRA) is the scientific evaluation of whether each ingredient in a product is safe at the concentrati...
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 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 detailsMedical 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 detailsFDA Medical Device Classification & Regulatory Pathway Report
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...
View full detailsMoCRA Serious Adverse Event Reporting Service
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...
View full detailsOTC Drug Establishment Registration + Labeler Code (FDA)
Sunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them mu...
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 detailsFDA Medical Device Establishment Registration & Listing
Medical device establishments selling in the US must register with FDA every year and list their devices. We prepare and submit registration and li...
View full detailsFresh Pineapple Musk For Men 1200 Perfume Oil Bulk Fragrance Oil
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...
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