Cosmetics & Personal Care

Qualitas offers a full suite of services designed to support every stage of your cosmetic and personal care product lifecycle and ensure adherence to critical quality and safety standards:

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  MoCRA Compliance Support: Effortlessly navigate the Modernization of Cosmetics Regulation Act (MoCRA) with our comprehensive guidance. We perform label reviews, formula safety reviews, claims substantiation, and product listings.
  

  Quality Management System (QMS) Development & Implementation: We create and maintain custom quality systems, providing ongoing Fractional Quality Management support for long-term success, built to comply with relevant regulations like ISO 22716.
  

  Internal Gap Assessments: We identify improvement opportunities within your QMS against applicable regulatory schemes, including ISO 22716, providing a clear roadmap for improvement.
  

  Supplier & Manufacturer Audits: We conduct thorough audits of your cosmetic and personal care suppliers' and co-manufacturers' processes and facilities to ensure alignment with your brand's quality standards, regulatory requirements, and overall business goals.
  

  Label Reviews: We meticulously review your product labels for regulatory compliance, offering suggestions to protect your brand and ensure label accuracy. This includes verification against requirements within 21 CFR Part 701.
  

  Formula Reviews: Our experts evaluate your formulations for safety, theoretical efficacy, and compliance, optimizing your go-to-market strategy by leaving no stone unturned.
  

  Claims Substantiation: We review your formula and existing claims to determine if they are supported by science and research, strengthening your marketing strategy and protecting your reputation.
  

  Marketing Copy Reviews: We ensure your marketing materials are compliant, claims are substantiated, and help build consumer trust and avoid common legal pitfalls.
  

  Website & Social Media Risk Assessment: Insulate your online presence from potential compliance risks by frequently reviewing the language and statements used by your entire team.
  

  Influencer & Sponsorship Compliance: Train your partner networks to use compliant marketing tactics to broaden the brand's reach without introducing unnecessary regulatory exposure.
  

  Product Safety Assessments: We thoroughly evaluate your product's safety profile to determine if there are potential consumer risks that must be addressed.
  

  Facility Registration: We register your facility within the applicable FDA database and issue a certificate of registration.
  

  Product Listings: We upload all of your technical and required information into Cosmetics Direct to make sure it's in an acceptable format.
  

  Investigations: We rapidly conduct expert investigations into quality issues, identifying root causes and implementing effective corrective actions.
  

  Fractional Quality Leadership Team: Our experts can function as an extension of your team, managing all quality and compliance needs for your cosmetics and personal care operations.
  

  Emergency Support Services: Offering rapid response for critical situations, including One-off Regulatory Inspection Support and FDA Warning Letter and 483 Remediation.