How much does GMP consulting cost?

GMP consulting costs vary based on your industry, facility size, and current compliance status. Initial gap assessments typically range from $5,000 to $15,000. Full implementation projects for supplement manufacturers (21 CFR 111) range from $15,000 to $40,000, while pharmaceutical manufacturers (21 CFR 210/211) may invest $25,000 to $75,000. The cost of non-compliance — including FDA warning letters, product recalls, and facility shutdowns — far exceeds the investment in proper GMP consulting.

What happens during an FDA GMP inspection?

During an FDA GMP inspection, investigators examine your facility, documentation, and processes against applicable regulations. They review batch production records, standard operating procedures, quality control testing, complaint handling, CAPA systems, and employee training records. Inspectors interview employees at all levels. The inspection typically lasts 2-5 days for supplement manufacturers and may extend to 1-2 weeks for pharmaceutical facilities. Any deficiencies are documented on FDA Form 483.

GMP Consultant | FDA GMP Consulting for Supplements, Cosmetics & Food

Industries We Serve

Specialized GMP consulting for every FDA-regulated manufacturing sector

Dietary Supplements

21 CFR Part 111 compliance. Gap analysis, documentation, training, and FDA inspection preparation for supplement manufacturers.

OTC Drug Manufacturing

21 CFR Parts 210 & 211 compliance. Quality systems, batch records, cleaning validation, and process controls for OTC manufacturers.

Cosmetics (MoCRA)

ISO 22716 and new MoCRA compliance. Mandatory GMP requirements now in effect for all cosmetics manufacturers.

Food Manufacturing

21 CFR Part 117 and FSMA Preventive Controls. Hazard analysis, process controls, and food safety management.

Why Work With a Specialist?

Most GMP consultants are generalists. Jared Clark holds the CPGP (Certified Pharmaceutical GMP Professional) — one of the few consultants in the country with this specialized credential plus a law degree, regulatory affairs certification, and food safety auditor certification.

CPGP + CFSQA + RAC

Triple-certified in pharmaceutical GMP, food safety auditing, and regulatory affairs. Unmatched cross-industry expertise.

JD + Regulatory Expertise

A law degree plus regulatory affairs certification means we don't just know the rules — we understand the legal framework behind every FDA regulation.

Practical, Not Academic

200+ clients across supplements, OTC drugs, cosmetics, and food manufacturing. Real-world systems that pass real FDA inspections.

CPGP

Certified Pharmaceutical GMP Professional

ASQ

CFSQA

Certified Food Safety & Quality Auditor

ASQ

RAC

Regulatory Affairs Certification

RAPS

JD

Juris Doctor

Law Degree

MBA

Master of Business Administration

Business

CMQ-OE

Certified Manager of Quality

ASQ

PMP

Project Management Professional

PMI

How We Get You Audit-Ready

A proven, step-by-step approach that has achieved 100% first-time audit pass rate across 200+ clients

1

Gap Analysis

Comprehensive assessment of your current systems against applicable FDA cGMP regulations. We identify every gap between where you are and where you need to be.

2

Documentation

Build your quality management system: SOPs, batch records, specifications, CAPA procedures, complaint handling, and training programs — all tailored to your operation.

3

Implementation

Hands-on deployment of your quality system. We train your team, execute process validations, run equipment qualifications, and verify every control is operational.

4

Mock Inspection

Full FDA-style mock inspection with employee interviews, document review, and facility walkthrough. You'll know exactly what to expect before the real thing arrives.

Proprietary Technology

Supercharge Your GMP Compliance With AI

Nova QMS is our proprietary AI-powered quality management platform — built from 200+ client engagements and designed for FDA-regulated manufacturers. Talk to your QMS. Let AI handle the rest.

Voice-First Interface

Hands-free data entry. Perfect for clean rooms and production floors. AI extracts structured data from natural speech.

Dual AI Verification

One AI drafts your records. A second audits them for compliance. Zero blind spots.

21 CFR Part 11 Ready

Electronic signatures, full audit trails, and access controls built in from day one.

Explore Nova QMS Try AI Engines Free

7

AI Engines

SOP Gap Analysis, Label Review, CAPA Draft, and more

$3-15

Per Run

Consultant-grade analysis at a fraction of the cost

15+

Record Types

Schema-driven, structured compliance data

Part 11

Compliant

FDA electronic records requirements built in

Case Study

Supplement Manufacturer Passes FDA Inspection in 4 Months

A growing dietary supplement company was expanding distribution to major retail chains, which required demonstrated FDA cGMP compliance. With no formal quality system in place and an FDA inspection expected within months, they needed to build a complete 21 CFR 111 quality system from scratch.

Complete quality system built in 16 weeks
Zero FDA 483 observations on first inspection
Secured retail distribution within 6 months

View All Case Studies

4

Months to Compliance

0

483 Observations

35+

SOPs Created

100%

Staff Trained

Frequently Asked Questions

A GMP consultant helps manufacturers achieve and maintain compliance with Good Manufacturing Practice regulations. This includes gap analysis against FDA regulations (21 CFR Parts 111, 210/211, 117), documentation system development, employee training, mock FDA inspections, 483 remediation, and audit preparation. The goal is ensuring your facility passes FDA inspections the first time.

GMP and cGMP refer to the same FDA regulations. The "c" stands for "current," emphasizing that manufacturers must use up-to-date systems and technologies. The FDA uses "cGMP" to signal that compliance is continuous — what was acceptable 10 years ago may not meet today's standards. Both terms are used interchangeably in the industry.

Most manufacturers achieve GMP compliance within 3 to 9 months with expert guidance. Companies with some quality systems in place may reach compliance in 3-4 months, while facilities starting from scratch typically need 6-9 months. Key factors include industry type, facility size, number of products, and resources dedicated to implementation.

Costs vary by industry and scope. Initial gap assessments range from $5,000 to $15,000. Full implementation for supplement manufacturers (21 CFR 111) typically runs $15,000 to $40,000, while pharmaceutical manufacturers (21 CFR 210/211) may invest $25,000 to $75,000. The cost of non-compliance — including warning letters, recalls, and shutdowns — far exceeds the investment in proper consulting.

FDA investigators examine your facility, documentation, and processes against applicable regulations. They review batch records, SOPs, quality control testing, complaint handling, CAPA systems, and training records. Inspectors interview employees at all levels. Inspections last 2-5 days for supplement manufacturers and may extend to 1-2 weeks for pharmaceutical facilities. Deficiencies are documented on FDA Form 483.

View All FAQs

Ready to Get GMP Compliant?

Schedule a free consultation with Jared Clark, CPGP, CFSQA, RAC. We'll assess your current state, identify the gaps, and build a clear roadmap to FDA compliance.

Schedule Free Consultation Call 858-240-4353

Achieve GMP Certification With Confidence