From your current facility to Amazon shelves and pharmacy aisles — GummyGMP LLC walks gummy supplement manufacturers through every step of the FDA cGMP certification journey.
What We Do
Every service is built exclusively for gummy supplement manufacturers — no generic pharma templates.
Gap assessments, SOP development, QMS implementation, and batch record systems tailored to your gummy production processes.
Learn more →Audit readiness preparation, documentation packages, pre-audit remediation, and finding response support to get you certified.
Learn more →Amazon supplement documentation, CoA preparation, quality dossier compilation, and Launchpad qualification support.
Learn more →Distributor qualification packages, third-party audit coordination, and quality dossier preparation for pharmacy channel entry.
Learn more →Urgent corrective action planning, observation-by-observation written responses, and CAPA documentation for FDA inspections.
Learn more →Gummy-specific process validation protocols, equipment qualification, and documentation to satisfy regulatory requirements.
Learn more →Formats We Support
Our GMP frameworks account for the unique manufacturing challenges of each gummy type.
The Process
A proven, structured path from your current facility to full GMP certification and retail readiness.
Client Results
Real outcomes from real facilities — under real deadline pressure.
We received an FDA 483 with 6 observations two days before our biggest retail launch. GummyGMP had a complete CAPA response drafted within 24 hours. Every observation was closed. We launched on time.
Amazon suspended our entire supplement catalog citing GMP documentation gaps. We had no COAs, no qualified lab, nothing. GummyGMP built our full documentation program from scratch in 3 weeks. All 14 ASINs reinstated.
Our NSF auditor found 23 SOP gaps during a pre-assessment. We had 60 days to close them or lose certification. GummyGMP delivered a complete gummy-specific SOP library in 11 days. We passed the audit clean.
New Feature — Free Tool
FDA cGMP compliance is your foundation — but retail expansion is your growth engine. Use our free Market Expansion Planner to map certifications, costs, and timeline for Amazon, Walmart, CVS, Walgreens, iHerb, and The Vitamin Shoppe.
Choose from 6 major retail channels. We map exactly which certifications each one requires — no guesswork.
Enter your facility profile and get an instant projection of Year 1 investment, annual recurring costs, and months to first-market access.
Your projection unlocks a consultation to review your actual gaps, scope the engagement, and build a binding project plan.
No account required · Takes under 2 minutes · Free forever
Tell us about your facility and goals. We'll map out exactly what it takes to get you GMP certified and retail ready.
Book a Free Call →