Services

This consultancy offers an integrated approach to product regulatory assurance, covering the following key areas:

1) Ingredient compliance review versus US (FDC Act / FPLA), Canada (Cosmetic Regulations), EU (Cosmetic Regulation) and UK (Cosmetic Regulation) requirements. Full spectrum MoCRA compliance services e.g., Product Listings

2) Regulatory documentation review with available compilation of a formula-specific Regulatory Master File (RMF)

3) Full spectrum CARB VOC compliance support

4) Claims development, including phraseology and substantiation

5) Label development and review, to meet the regulatory requirements of the US, Canada, UK and EU or any combination thereof

6) Pre-market cosmetic product submissions, via on-line entry of Cosmetic Notification Forms to Health Canada and Cosmetic Listings to the US FDA, as required by MoCRA

7) Product Information File (PIF) compilation (as a condensed e-PIF) to meet UK and EU requirements, including a signed safety assessment by a twice Certified EU Safety Assessor

This consultancy practices  a "bottom up...top down" approach to product safety assurance, encompassing the following interrelated areas:

1) Ingredient safety review with Quantitative Risk Assessment (QRA) where applicable (After all, safe ingredients at safe levels tend to make safe products!)

2) Formula safety and claims substantiation test plan specification, with available End to End Study Stewardship Services (E2E-SSS) including completion of test article submission forms, protocol development, tracking and interpretation of results and delivery of a fully audited Final Test Report, all using an expert network of chemical, clinical, microbiological and in-vitro testing lab partners

3) Directions and Warnings recommendations, encompassing both regulatory requirements and due diligence considerations

4) Non-routine problem solving, e.g., 

    a. Chemical contaminant identification, traceability and remediation

    b. Technical scientific support to investigations of suspected counterfeit 

          cosmetic products