⚠️ Received an FDA 483? Call 1-888-923-5487 immediately — urgent response support available.
What We Offer

GMP Consulting Services

Every service is designed specifically for gummy supplement manufacturers — not adapted from generic pharma consulting templates.

Compliance at Every Stage

From first-time certification to emergency FDA response, GummyGMP LLC covers every compliance need your facility will face.

📋

21 CFR Part 111 Compliance

The foundation of every legitimate dietary supplement operation. We guide gummy manufacturers through full compliance with FDA's Current Good Manufacturing Practice regulations — building systems that satisfy inspectors and protect your product quality.

What's Included

  • Gap Assessment against 21 CFR Part 111
  • SOP Development (gummy-specific)
  • QMS Implementation
  • Batch Record Design & Templates

Also Includes

  • Laboratory Testing Programs
  • Supplier Qualification System
  • Personnel Training Programs
  • Mock Inspection Preparation
🏅

NSF GMP Certification

NSF certification is the gold standard for dietary supplement manufacturing and is increasingly required by major retailers. We prepare your facility end-to-end for the NSF audit process and see you through to a successful certification.

What's Included

  • NSF Audit Readiness Assessment
  • Documentation Package Preparation
  • Pre-Audit Remediation
  • Auditor Coordination & Scheduling

Also Includes

  • Written Finding Responses
  • Certificate Procurement Support
  • Annual Surveillance Preparation
  • Ongoing Compliance Maintenance
Selling on Amazon under your own brand? See our Seller Compliance services →
🛒

Amazon & Retail Compliance

Contract manufacturers and co-packers need documentation that clears Amazon's third-party verification for every SKU leaving the facility. We build GMP certificate packages, CoA programs, and Amazon compliance dossiers from the plant's output — so your customers can list, and you don't get pulled into their TIC submissions.

What's Included

  • Amazon Supplement Documentation
  • Certificate of Analysis (CoA) Preparation
  • Quality Dossier Compilation
  • Amazon Launchpad Qualification

Also Includes

  • Listing Compliance Review
  • Ongoing Document Maintenance
  • Retailer Qualification Support
  • Third-Party Testing Coordination
💊

Pharmacy Approval

Pharmacy and healthcare distributor channels require a higher level of quality documentation and credentialing than typical retail. We build the packages that qualify your manufacturing facility for these premium distribution channels.

What's Included

  • Distributor Qualification Packages
  • Third-Party Audit Coordination
  • Quality Dossier Preparation
  • CoA Documentation System

Also Includes

  • Stability Program Development
  • Pharmaceutical-Grade SOP Review
  • Distributor Questionnaire Support
  • Ongoing Compliance Maintenance

Not Sure Which Service You Need?

Book a free 30-minute discovery call. We'll review your situation and tell you exactly what your facility needs — and what it doesn't.

Book Your Free Call →