Dietary Supplement Quality, Specifications & cGMP Readiness

What's typically included

• 21 CFR Part 111 gap assessment — structured review of the brand's quality system, specifications, records, and supplier oversight against the cGMP rule, with the most material gaps prioritized.
• Specification review — senior read on component, in-process, and finished-product specifications, and whether they actually tie the formulation, the label, and the testing together.
• Label claim alignment — checking that what the label says is what the specifications and release testing actually support.
• Importer / manufacturer responsibility mapping — clarifying which obligations sit with the brand owner, which sit with the contract manufacturer, which sit with the importer, and where the current arrangement leaves a gap.
• Launch-readiness check — quality and documentation readiness against retailer expectations and audit exposure before the product ships.

When this is the right conversation

Brand owners typically engage RGM here when a supplement is moving toward launch and quality readiness has not been independently reviewed; when an importer is bringing a foreign-manufactured product into the U.S. and the responsibility split needs to be made explicit; when a retailer audit or quality questionnaire has surfaced gaps; or when a 483, warning letter, or recall in the category has prompted leadership to want an outside read on its own exposure.

Output you can use

A prioritized 21 CFR Part 111 gap assessment with the material findings called out, a documented view of where specifications and label claims line up and where they don't, a responsibility map that names what sits with the brand, the manufacturer, and the importer, and a practical readiness recommendation for launch. Written so it can drive quality investment decisions at the leadership table.