200+ companies guided to GMP compliance. 100% first-time audit pass rate. Supplements, OTC drugs, cosmetics, and food manufacturing.
Expert guidance through FDA regulations — 21 CFR 111, 210/211, 117, and ISO 22716. From gap analysis to audit day.
Specialized GMP consulting for every FDA-regulated manufacturing sector
21 CFR Part 111 compliance. Gap analysis, documentation, training, and FDA inspection preparation for supplement manufacturers.
21 CFR Parts 210 & 211 compliance. Quality systems, batch records, cleaning validation, and process controls for OTC manufacturers.
ISO 22716 and new MoCRA compliance. Mandatory GMP requirements now in effect for all cosmetics manufacturers.
21 CFR Part 117 and FSMA Preventive Controls. Hazard analysis, process controls, and food safety management.
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.
Triple-certified in pharmaceutical GMP, food safety auditing, and regulatory affairs. Unmatched cross-industry 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.
200+ clients across supplements, OTC drugs, cosmetics, and food manufacturing. Real-world systems that pass real FDA inspections.
Certified Pharmaceutical GMP Professional
ASQ
Certified Food Safety & Quality Auditor
ASQ
Regulatory Affairs Certification
RAPS
Juris Doctor
Law Degree
Master of Business Administration
Business
Certified Manager of Quality
ASQ
Project Management Professional
PMI
A proven, step-by-step approach that has achieved 100% first-time audit pass rate across 200+ clients
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.
Build your quality management system: SOPs, batch records, specifications, CAPA procedures, complaint handling, and training programs — all tailored to your operation.
Hands-on deployment of your quality system. We train your team, execute process validations, run equipment qualifications, and verify every control is operational.
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.
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.
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.