FDA-Regulated Industries

GMP Certification
Consultant

I can help you achieve GMP certification quickly and affordably. Complete readiness with our LeanGMP System™ included at no cost.

"Keep it Simple. Keep it Real."

Schedule Free Consultation 858-240-4353

GMP compliance is required by the FDA; however, GMP certification is not required. But customers trust you when you provide your GMP certificate. Let me help you achieve that trust.

Industries We Serve

FDA-Regulated Industries

GMP certification consulting for every FDA-regulated manufacturing sector.

Dietary Supplements

21 CFR 111

Current Good Manufacturing Practice for dietary supplement manufacturing, packaging, labeling, and holding operations.

OTC Drugs

21 CFR 211

Current Good Manufacturing Practice for finished pharmaceutical products including over-the-counter drug manufacturing.

Cosmetics

21 CFR 700-740

Good Manufacturing Practice for cosmetic products including skincare, hair care, and personal care manufacturing.

Food Manufacturing

21 CFR 117

Current Good Manufacturing Practice, hazard analysis, and risk-based preventive controls for human food manufacturing.

Active Pharmaceutical Ingredients

ICH Q7

Good Manufacturing Practice guidance for active pharmaceutical ingredients. International harmonized standard for API production.

What We Cover

GMP Consulting Areas

Our GMP consulting covers every area required for FDA compliance and third-party certification. We build your quality system from the ground up or improve what you already have.

Jared Clark
Founder & Lead Consultant
Production and Quality Assurance

Manufacturing controls, in-process testing, batch production records

Facilities and Equipment

Facility design, equipment qualification, calibration programs

Laboratory Controls

Testing methods, specifications, stability programs, lab procedures

Cleaning and Sanitation

Cleaning validation, sanitation procedures, pest control programs

Raw Materials and Finished Product

Supplier qualification, incoming inspection, release procedures

Packaging and Labeling

Label controls, packaging line clearance, artwork management

Validation and Document Control

Process validation, method validation, document management systems

Nonconformities, CAPAs, Recall & Traceability

Corrective actions, complaint handling, recall procedures, lot traceability

Our Proven Process

8-Step GMP Certification Methodology

A proven, repeatable process that has achieved 100% certification success across 200+ clients. Includes the LeanGMP System™ at no additional cost.

1

Gap Assessment

GMP Requirements Matrix traceable to FDA regulations. Identify gaps and build your action plan.

2

Documentation

SOPs, batch records, forms, and revision control. All documentation aligned to your FDA requirements.

3

HACCP Risk Assessment

HACCP builder, templates, and risk tools. Systematic hazard analysis for your manufacturing processes.

4

Implementation

Project management and consultant oversight. We guide you through every implementation step.

5

GMP Training

Online courses, HACCP training, and training records. Ensure your team is audit-ready.

6

Workflows & Controls

Automations, notifications, and modules. Streamline your quality system with built-in workflows.

7

Inspections & Audits

Mobile inspections and customizable checklists. Be ready for FDA inspections and third-party audits.

8

Metrics & Monitoring

Dashboards, metrics, and widgets. Track your GMP performance and drive continuous improvement.

Included At No Cost

The LeanGMP System™

Every GMP consulting engagement includes our proprietary LeanGMP System™ — a complete digital quality management platform designed specifically for FDA-regulated manufacturers.

  • GMP Requirements Matrix traceable to FDA regulations
  • Document control with SOPs, forms, and revision management
  • HACCP builder and risk assessment tools
  • Online training courses and training records
  • Mobile inspections and audit checklists
  • Dashboards, metrics, and real-time monitoring
$0
Additional Cost

The LeanGMP System™ is included with every GMP consulting engagement. No extra fees, no hidden costs.

Get Started Today

Certification Options

Choose Your GMP Certification Body

We prepare you for certification from any of these recognized certification bodies.

Food & Beverage

  • ASI — American Sanitation Institute
  • SQF — Safe Quality Food
  • BRC — British Retail Consortium

Dietary Supplements

  • NPA/UL — Natural Products Association / UL
  • NSF — National Sanitation Foundation
  • USP — United States Pharmacopeia

Ready to Get GMP Certified?

Schedule a free 30-minute consultation. We'll assess your GMP needs, outline a clear path to certification, and answer all your questions — no obligation.

Schedule Free Consultation Call 858-240-4353

Or email us at support@certify.consulting