Dietary Supplements

EMMA International specializes in providing comprehensive regulatory and compliance support tailored to the unique needs of dietary supplements manufacturers. EMMA International offers in-depth knowledge of FDA regulations, including Current Good Manufacturing Practices (cGMP), New Dietary Ingredient (NDI) notifications, and labeling requirements.

Our Dietary Supplement Services

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Facility and Supplier Audits

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Labeling and Health Claims Review

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New Dietary Supplement Notification and GRAS

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Recall Support

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Facility Registrations

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483 and Warning Letter Remediation

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US Agent and Import Assistance

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Due Diligence Assessments

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Stability Program Development

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Quality Management System Development and Optimization

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Training Programs and Support

Trust the experts at EMMA International to ensure complete compliance of your operations to the Dietary Supplement Health and Education Act (DSHEA), as well as GMP regulations (21 CFR part 111). EMMA International is committed to supporting dietary supplement manufacturers and distributors in achieving and maintaining regulatory compliance. From comprehensive regulatory assessments to proactive GMP guidance and crisis management support, our services are designed to streamline the compliance journey and uphold product safety and integrity.

If you’re ready to enhance your compliance strategy or have specific regulatory concerns, partner with EMMA International for expert guidance and support. Contact us today to discuss how we can assist you on your compliance journey in the dietary supplement industry. With EMMA International by your side, you can navigate regulatory complexities with confidence and focus on driving success in the marketplace.