Cosmetics and Consumer Products

Safety Assessment:

  • Preparation of a comprehensive Cosmetic Product Safety Report (CPSR) according to the EC Reg 1223/2009

  • Expert guidance on the final formula for both US and international marketplaces, ensuring that your products comply with all necessary regulations

  • Conduct preclinical toxicological profiling for ingredients

  • Recommendations on safe use-levels for raw materials and ingredients

  • Review fragrances and flavors to ensure safe use

  • Prop 65 compliance guidance

  • Impurities qualification

  • Expert guidance on NAMs, in silico tools, TTC approaches, QRA for dermal sensitization

  • Facilitate Seal of Recommendation or Acceptance:

Safety Testing:

  • Recommendations on appropriate clinical testing for products

  • Study placement and guidance on a variety of in vitro tox studies for various endpoints, such as:

    • Eye irritation

    • Skin Irritation

    • Skin Sensitization

    • Phototoxicity

    • Genotoxicity

    • Skin Absorption

Claims/Performance Testing:

  • Recommendations on the study need

  • Help finalize the study design

  • Collaborate with testing facilities

  • Study placement and monitoring

  • Reviewing and interpreting test results

Regulatory:

  • Serve as a Responsible Person, as defined in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), to:

    • List cosmetic products with the FDA

    • Ensure and maintain product-safety records

    • Report serious adverse events to the US FDA

  • Notify Health Canada > Cosmetic Notification Form (CNF)

  • Formulation review to ensure compliance with Reg (EC) No 1223/2009

  • Help facilitate CPNP notification

  • Facilitate compilation of Product Information File (PIF)

  • Formulation review to ensure compliance with the ASEAN Cosmetic Directive (ACD)

  • Artwork/label review

  • Recommendation on Cautionary Statements and Label Warning

  • Assist with a variety of regulatory compliance issues, including:

    • Addressing audit-associated queries

    • Providing guidance on international registration/notification requirements

    • Facilitating INCI registration

  • Facilitate meeting regulatory requirements of various countries such as European, China, Turkey, Indonesia, Singapore, Thailand, India, Saudi Arabia, Brazil, and more

Other:

  • We offer recommendations on the following to ensure the quality and safety of your products:

    • Packaging material requirements

    • Stability testing requirements

    • Micro-testing requirements

    • Product testing for contaminants (Heavy Metals, Nitrosamines, Benzene, 1,4 Dioxane, Ethylene Oxide, Acrylamide, and more )

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