Dietary Supplements

Expert Quality Management & Compliance for the Dietary Supplement Industry.

The dietary supplement industry is a dynamic sector that demands stringent quality management and unwavering regulatory compliance. At Qualitas, we specialize in providing tailored solutions for Dietary Supplements brands and manufacturers, ensuring your products not only meet the highest standards of safety and efficacy but also navigate the complex regulatory landscape with confidence. We streamline processes, reduce risk, and fuel growth, empowering you to thrive in this highly regulated environment.

Why Qualitas for Your Dietary Supplement Business?

Successfully bringing dietary supplements to market requires a deep understanding of FDA regulations, Good Manufacturing Practices (GMPs), and ongoing quality assurance. From raw material sourcing to finished product release, 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.

Our Comprehensive Dietary Supplement Services:

Qualitas offers a full suite of services designed to support every stage of your dietary supplement product lifecycle:

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 FDA 21 CFR Part 111 (Dietary Supplement cGMPs).
Internal Gap Assessments: We identify improvement opportunities within your QMS against FDA 21 CFR Part 111, providing a roadmap for improvement.
Supplier & Manufacturer Audits: We conduct thorough audits of your dietary supplement suppliers' and co-manufacturers' processes and facilities to ensure alignment with your brand's quality standards, regulatory requirements, and business goals.
Label Reviews: We meticulously review your dietary supplement product labels for regulatory compliance, offering suggestions to protect your brand and ensure label accuracy.
Formula Reviews: Our experts evaluate your dietary supplement formulations for safety, theoretical efficacy, and compliance, optimizing your go-to-market strategy.
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 for dietary supplements.
Marketing Copy Reviews: We ensure your dietary supplement marketing materials are compliant, claims are substantiated, and help build consumer trust.
Product Safety Assessments: We thoroughly evaluate your dietary supplement product's safety profile to determine potential consumer risks.
Facility Registration: We register your facility within the applicable FDA database and issue a certificate of registration, simplifying compliance with regulatory agencies.
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 dietary supplement operations.
Emergency Support Services: Offering rapid response for critical situations, including One-off Regulatory Inspection Support and FDA Warning Letter and 483 Remediation.

Achieve Unwavering Compliance and Accelerated Growth.

Partner with Qualitas to ensure your dietary supplement products meet the highest quality benchmarks, maintain full regulatory compliance, and build a foundation for sustained success.

Ready to Optimize Your Dietary Supplement Operations?

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

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