Full Service List

At Qualitas, we are experts in the CPG industry, providing professional quality management solutions that streamline your business, reduce risk, and fuel growth. We design scalable, practical systems that simplify processes and help you thrive in highly regulated, constantly evolving industries.
Industries we serve:

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  Dietary Supplements
  

  Cosmetics & Personal Care
  

  Food & Beverage
  

  OTC (Over-the-Counter)
  

  Exempt Medical Devices

Our services vary and cover every aspect of quality and compliance you may need, whether you’re starting from the ground up, refining existing systems, or looking for fractional support. Find what you’re looking for below. 

Building an enduring quality system is an ongoing journey. Our proactive support and expertise help you anticipate challenges, adapt to changing requirements, and maintain consistently high standards.

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  Quality and/or Compliance System Development, Implementation, & Support: We create and maintain custom quality systems and can provide optional ongoing Fractional Quality Management support for long-term success.
  

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

  Team Development: Build a compliance-savvy workforce to reduce risks.
  

  Fractional Quality Leadership Team: Our experts function as an extension of your team, managing all quality and compliance needs, with access to our wide professional network.
  

  Advisory Board Support: Receive expert strategic and tactical guidance on your most complex quality and compliance challenges.

We don't just react to challenges; we anticipate them. Our proactive solutions strengthen your foundation by reviewing your quality systems from start to finish.

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  Manufacturer Gap Assessments: We identify opportunities for positive change within your quality system, providing a roadmap for improvement and a strong foundation for Fractional Quality Management.
  

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

  Brand Gap Assessments: We review the current state of your quality operations against regulatory and industry best practices to build a custom-tailored action plan. Our internal benchmarking process will show you how you perform vs your competitors.
  

  Compliance Management Strategy: We develop a roadmap to help keep your business ahead of regulatory enforcement trends.

We offer comprehensive technical review services that go beyond the basic requirements, diving into the details to ensure everything is accurate, compliant, and adheres to industry best practices, helping you be prepared for whatever headwinds your business faces.

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  Label Reviews: Meticulous review of product labels for regulatory compliance, with suggestions to protect your brand and ensure accuracy.
  

  Formula Reviews: Evaluation of formulations for safety, theoretical efficacy, and compliance, optimizing your go-to-market strategy.
  

  Marketing Copy Reviews: Ensuring marketing materials are compliant, claims are substantiated, and consumer trust is built.
  

  Website & Social Media Risk Assessment: Insulating your online presence from potential compliance risks.
  

  Influencer & Sponsorship Compliance: Training partner networks to use compliant marketing tactics, broadening reach without regulatory exposure.
  

  Claims Substantiation: Reviewing formulas and existing claims to determine if they are supported by science and research.
  

  Product Safety Assessments: Thorough evaluation of product safety profiles to determine potential consumer risks.

We simplify complex processes across a variety of CPG categories, helping clients succeed in dynamic regulatory environments through process mapping, automation, and continuous improvement.

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  Facility Registration: Registering your facility within applicable FDA databases and issuing a certificate of registration for compliance.
  

  Product Listings: Uploading technical and required information into platforms like FDA’s Cosmetics Direct portal for confident product launches.
  

  MoCRA Compliance Support: Comprehensive guidance to effortlessly navigate the Modernization of Cosmetics Regulation Act (MoCRA), including label reviews, formula safety reviews, claims substantiation, and product listings.
  

  Positioning Support: Identifying your risk tolerance to build a strategic regulatory compliance roadmap aligned with business goals.

Rapid response when you need it most.

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  One-off Regulatory Inspection Support (24-hour deployment): On-demand support for regulatory inspections, available within one business day.
  

  Contract Manufacturer Dispute Resolution: Subject matter expert support for resolving disputes. We can do this for you or ghostwrite responses you can send to the other party.
  

  Expert Witness Testimony: Providing credible expert witness testimony for legal proceedings.
  

  360-Degree Compliance Claims/Brand Risk Assessment: Comprehensive assessment of product claims and potential brand risks.
  

  Remote Quality Management (Reviews/Reports/Releases): Remote management of quality systems, including reviews, reporting, and product releases.
  

  FDA Warning Letter and 483 Remediation: Guidance and support in remediating FDA warning letters or 483s.
  

  Interim Technical Team Leadership: Temporary leadership solutions for your technical team.