Dietary Supplement Consulting

Built for 21 CFR Part 111, From Bench to Label

Whether you are a contract manufacturer or a brand with your own facility, we make sure your operation meets the standard: specifications and identity testing for every dietary ingredient, in-process controls that catch problems early, label claims that match what is actually in the bottle, and batch documentation that tells the whole story. We also support companies preparing for third-party GMP certification audits from organizations like NSF and SQF. For the regulation itself, see FDA's official dietary supplements resources.

• 21 CFR Part 111 compliance
• Identity testing and specification programs
• SOP development and staff training
• Label claims verification
• Batch record and documentation systems
• Third-party GMP certification readiness

The Full Compliance Path for Supplement Companies

Most supplement engagements start with a GMP gap analysis against Part 111, continue through process design and SOP development where systems are missing, and end with GMP certification support when a retailer or customer asks for the certificate. If FDA has already been in the building, our GMP remediation programs turn 483 observations into closed findings. Onsite across California, remote nationwide.

Dietary Supplement Questions

What GMP requirements apply to dietary supplements?

Dietary supplement manufacturers must comply with 21 CFR Part 111, which covers identity testing, in-process controls, label claims verification, and proper documentation. We help supplement companies build quality systems that meet the standard and prepare for third-party GMP certification audits from NSF and SQF.

What is identity testing for supplements?

21 CFR Part 111 requires manufacturers to verify the identity of dietary ingredients before use, using scientifically valid methods. We help you build identity testing and specification programs that satisfy the regulation and hold up in audits.

We use a contract manufacturer. Are we still responsible?

Yes. Brands that put their name on the label keep quality responsibilities under Part 111, including verifying that products meet specifications and keeping proper records. We help brands set up supplier qualification and verification programs that cover exactly this.

Can you prepare us for NSF or SQF certification?

Yes. We support companies preparing for third-party GMP certification audits from organizations like NSF and SQF, from readiness assessment through the audit itself.