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Expertise to ensure Compliance with US FDA Cosmetic Regulations for USA market
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Cosmetic Facility Registration with US FDA as per MOCRA: Experience in managing regulatory submissions for Cosmetic Facility Registration as required under US FDA MOCRA [Modernization of Cosmetics Regulation Act of 2022].
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US Federal Legislation (MoCRA & existing regulations): Formula Review –expertise in performing an evaluation of complete formula to ensure that raw materials and ingredients comply with federal requirements.
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US Federal Legislation (MoCRA & existing regulations): Label and Claims Review – expertise in performing an evaluation of product labels to ensure that the mandatory elements and the marketing communications that are proposed cannot get you into serious trouble.
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US Federal Legislation & California Provisions: Management of Volatile Organic Compounds (EPA, California Air Resources Board) – These substances, which can easily become vapors or gases, are regulated due to environmental concerns.
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California’s specific requirements: Proposition 65
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Expertise to ensure Compliance with US FDA Over-the-counter Drug Regulations
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Experience in managing regulatory submissions for Over-the-counter Drug Establishment Registration of facility for manufacturing of products which are classified as OTC drugs in USA as required by US FDA.
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Experience in managing regulatory submissions for Over-the-counter Drug listing for products [like Sunscreen] which are classified as OTC drugs in USA as required by US FDA.
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Expertise in ensuring OTC product [Sunscreen] compliance with US OTC Drug monographs
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Experience in managing efficacy testing requirements as per US FDA
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Expertise in ensuring EU Cosmetics Compliance as accordance with EU cosmetic regulation 1223/2009
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Expertise in ensuring your products meet the requirements of transversal legal acts such as: REACH Regulation (EC No 1907/2006); Fluorinated Greenhouse Gases Regulation (EU No 517/2014)
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Thorough Formula Review and Compliance check:
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Verification of the regulatory and safety compliance of the ingredients (eventual restricted or prohibited ingredients)
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Establishment of the INCI List or Ingredients List
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Confirmation and validation of the mandatory laboratory tests performed on the finished product
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Ensure that products comply with key regulatory articles, including:
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Article 14: Prohibited and restricted cosmetic ingredients
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Article 15: CMR (Carcinogenic, Mutagenic, or Reprotoxic) ingredients
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Article 16: Nanomaterials
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Article 17: Unavoidable traces of prohibited substances
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Article 18: No animal testing
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Review of cosmetics formula to ensure that all ingredients are safe for their intended use and comply with the EU Cosmetic Regulations:
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Determination of warnings and specific conditions of use
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Raw Material documentation (Safety Data Sheet, Technical Data Sheet, Allergen Report, IFRA Certificate, etc. )
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Finished Product tests (Stability/Compatibility, Microbiological Analysis, Safety Tests, etc.)
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The review is based on the composition expressed in the raw materials trade names.
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The documentation of each raw material is reviewed to verify its regulatory compliance, and the impurities profile is highlighted.
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Experience in managing European Union regulatory safety assessments like PIF [product Information File] , Cosmetic Product Safety Report in accordance to EU cosmetic Regulation (EC) No 1223/2009.
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mandatory Cosmetic Product Safety Report (CPSR) for the EU and UK, evaluating product’s safety to meet regulatory standards before market entry.
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Skilled in pre-evaluations of cosmetic formulas which are under the research and development phase of products to determine and verify that the safety margins calculated for each ingredient are acceptable.
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CPNP/SCNP Notification: Experience in submitting product details to both the EU's Cosmetic Products Notification Portal (CPNP) and the UK’s Submit Product Notification Portal (SCNP) for regulatory compliance assuring product meets both EU and UK standards.
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Label Reviews: Experience in label review of cosmetic labelling as per UK and EU regulations Article 19 requirements and compliant claims. Expert in product write up to align labels with regulatory standards while showcasing brand effectively.
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Proficient in interpreting and implementing FDA, EU, and other global regulations and guidelines.
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Proven track record of successful interactions with regulatory agencies and notified bodies.
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Skilled in preparing technical documentation and providing regulatory support for product development and commercialization.
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Strong understanding of quality management systems and regulatory compliance requirements.
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Monitored changes in regulatory requirements and provided guidance to internal teams on regulatory compliance.
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Conducted in-depth review of regulatory documents and submissions to ensure accuracy.
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Developed regulatory plans for new products and managed the approval process.