OTC & Other CPG

Expert Quality Management & Compliance for OTC and Diverse CPG Products.

The Over-the-Counter (OTC) drug market and the broader landscape of "Other CPG" (Consumer Packaged Goods) categories demand rigorous adherence to quality and regulatory standards unique to their product classifications. At Qualitas, we specialize in providing tailored solutions forOTC & Other CPG brands and manufacturers, ensuring your products not only meet the highest benchmarks for safety, efficacy, and quality but also navigate their distinct regulatory pathways with complete confidence. We streamline processes, reduce risk, and fuel growth, empowering you to thrive in these specialized and often highly scrutinized sectors.

Why Qualitas for Your OTC & Other CPG Business?

Successfully bringing OTC drugs or other diverse CPG products to market requires a deep understanding of specific manufacturing requirements, labeling laws, claims substantiation, and ongoing post-market surveillance. Our proactive support and expertise help you anticipate challenges, adapt to changing requirements, and maintain consistently high standards. We are rooted in integrity and driven by expertise, delivering proactive, no-nonsense guidance to help your business succeed.

Our Comprehensive OTC & Other CPG Services:

Qualitas offers a full suite of services designed to support every stage of your OTC and other CPG product lifecycle and ensure adherence to critical quality and safety standards:

Quality Management System (QMS) Development & Implementation: We create and maintain custom quality systems, providing ongoing Fractional Quality Management support for long-term success. These systems are built to comply with relevant regulations specific to your CPG category.
Internal Gap Assessments: We identify improvement opportunities within your QMS against applicable regulatory schemes, providing a clear roadmap for improvement and a strong foundation for Fractional Quality Management.
Supplier & Manufacturer Audits: We conduct thorough audits of your suppliers' and co-manufacturers' processes and facilities to ensure alignment with your brand's quality standards, regulatory and certification 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.
Formula Reviews: Our experts evaluate your formulations for safety, theoretical efficacy, and compliance, optimizing your go-to-market strategy by leaving no stone unturned.
Marketing Copy Reviews: We ensure your marketing materials are compliant, claims are substantiated, and you have the tools to 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.
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.
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.
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.
Emergency Support Services: Offering rapid response when you need it most , including One-off Regulatory Inspection Support (24-hour deployment) and FDA Warning Letter and 483 Remediation

Ensure OTC & CPG Quality, Safety, and Regulatory Confidence.

Partner with Qualitas to ensure your OTC drugs and other CPG products meet the highest quality benchmarks, maintain full regulatory compliance, and build a foundation for sustained success in their respective markets.

Ready to Optimize Your OTC or Other CPG Operations?

Contact Qualitas today for a tailored solution that secures your regulatory positioning and propels your business forward.

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