Dietary Supplement Consultant | Certify Consulting

Expert Support

What Does a Dietary Supplement Consultant Do?

A dietary supplement consultant helps supplement companies implement and maintain FDA-compliant Good Manufacturing Practice (GMP) systems under 21 CFR Part 111. This is not a one-time project — it is an ongoing commitment to quality and regulatory compliance.

Your consultant serves as your subject matter expert for all things GMP. From the initial gap assessment through documentation development, training, and audit preparation, a qualified consultant ensures your company meets every FDA requirement efficiently and without wasted effort.

The right consultant does not just build a system and leave. They provide ongoing compliance support, help you respond to FDA observations, implement corrective actions, and continuously improve your quality systems as your business grows.

Gap Assessments

Comprehensive evaluation of your current operations against FDA 21 CFR Part 111 requirements.

Documentation Development

SOPs, batch records, master manufacturing records, and all required GMP documentation.

Training Programs

GMP training for all personnel involved in supplement manufacturing and quality operations.

Audit Preparation

Mock FDA inspections and comprehensive audit readiness reviews.

Corrective Actions & Ongoing Support

CAPA implementation, continuous compliance monitoring, and long-term quality system maintenance.

FDA Enforcement Is Increasing

Why You Need a Supplement Consultant

The FDA is increasing enforcement actions against dietary supplement companies. The cost of non-compliance far exceeds the investment in proper GMP systems.

Warning Letters

FDA warning letters are public record and can damage your brand reputation, trigger retailer delistings, and lead to further enforcement actions.

Import Alerts & Seizures

Non-compliant products can be detained at the border or seized from the market. Product recalls cost companies millions and destroy consumer trust.

Pass the First Time

A qualified consultant ensures you pass FDA inspections the first time and maintain continuous compliance. Prevention is always cheaper than remediation.

Your Dedicated Expert

Jared Clark — Your Supplement Consultant

When you work with Certify Consulting, you work directly with Jared Clark — not a rotating team of junior consultants. One expert, one relationship, one point of accountability for your entire compliance project.

PMP

Project Management Professional

CMQ-OE

Certified Manager of Quality

CPGP

Certified Professional in GMP

CFSQA

Certified Food Safety & Quality

200+ clients across FDA-regulated industries
100% audit pass rate — no client has ever failed
Not a big firm — one expert managing your project directly
Deep experience with dietary supplement, pharmaceutical, and food safety regulations

Jared Clark

Principal Consultant

PMP | CMQ-OE | CPGP | CFSQA

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Comprehensive Consulting

Services We Provide

Everything you need to achieve and maintain FDA GMP compliance for your dietary supplement operation.

GMP Gap Assessment

Full evaluation against 21 CFR Part 111 with detailed action plan.

Documentation Development

SOPs, batch records, specifications, and all required GMP documents.

Process Validation Protocols

Validation plans and protocols for manufacturing processes.

Supplier Qualification Programs

Vendor approval, COA review, and supplier audit programs.

Training Programs

Comprehensive GMP training for all production and quality personnel.

Mock FDA Inspections

Simulated inspections to ensure your team is ready for the real thing.

CAPA System Implementation

Corrective and preventive action systems for continuous improvement.

Label Compliance Review

Supplement facts panel, claims, and labeling compliance under FDA rules.

Common Questions

Frequently Asked Questions

How do I choose a dietary supplement consultant?

Look for a consultant with direct experience in FDA 21 CFR Part 111 compliance, relevant certifications (such as PMP, CMQ-OE, CPGP, or CFSQA), a proven track record with dietary supplement companies, and a clear, structured methodology. Avoid large firms where your project gets handed off to junior staff. The best consultants offer a dedicated, hands-on approach and can demonstrate a history of successful FDA inspections.

Can you help prepare for an FDA inspection?

Absolutely. FDA inspection preparation is one of our core services. We conduct mock FDA inspections that simulate the actual inspection experience, review all documentation for completeness and accuracy, train your staff on how to interact with FDA investigators, identify and correct any compliance gaps before the inspector arrives, and provide on-call support during the actual inspection if needed.

Do you work with startups or only established companies?

We work with companies at every stage — from startups launching their first supplement product to established manufacturers looking to improve their existing quality systems. For startups, we help build GMP-compliant systems from the ground up, which is actually more cost-effective than retrofitting non-compliant processes later. For established companies, we identify gaps and implement targeted improvements to bring your operations into full compliance. Learn more about our supplement GMP services.

Ready to Work with a Supplement Expert?

Schedule a free 30-minute consultation with Jared Clark. We'll discuss your compliance needs, outline a clear path forward, and answer all your questions — no obligation.

Schedule Free Consultation Call 858-240-4353

Or email us at [email protected]