Meet Your GMP Consultant — Jared Clark

Experience

Built on Real-World GMP Implementation

Jared's path to GMP consulting wasn't theoretical. Before founding Certify Consulting LLC, he spent years embedded in FDA-regulated manufacturing environments — writing SOPs, building quality management systems from scratch, training production teams, and preparing facilities for FDA inspections. That hands-on experience is what separates his approach from consultants who only know regulations from a textbook.

Every engagement begins with understanding your specific manufacturing environment, product portfolio, and regulatory exposure. Whether you manufacture dietary supplements under 21 CFR Part 111, OTC drugs under 21 CFR Parts 210 and 211, cosmetics under MoCRA, or food products under 21 CFR Part 117, Jared tailors every compliance program to your actual operations — not a generic template.

His legal background (JD) adds a dimension that most GMP consultants simply cannot provide. Jared reads FDA warning letters, consent decrees, and enforcement actions the way they were written — as legal documents with specific regulatory implications. That analytical precision translates directly into more defensible quality systems, stronger CAPA programs, and documentation that holds up under FDA scrutiny.

Philosophy

Compliance That Lasts Beyond the Inspection

Too many GMP consulting engagements focus on passing the next inspection. Jared takes a different approach: building quality systems that your team owns and operates independently long after the consulting engagement ends. The goal is not to create dependency — it's to build internal capability.

This philosophy is reflected in how every project is structured. Documentation isn't just compliant — it's written so your production staff actually understands and follows it. Training isn't a checkbox exercise — it's designed so your team can identify and correct GMP deviations in real time. FDA inspection preparation isn't last-minute scrambling — it's the natural outcome of systems that were built right from the beginning.

Jared's project management expertise (PMP) ensures that compliance projects stay on schedule and within budget. His quality management credentials (CMQ-OE, CPGP) guarantee that the systems he builds meet the highest professional standards. And his regulatory affairs certification (RAC) means he stays current with evolving FDA expectations, guidance documents, and enforcement trends.

The result: your facility passes inspections not because someone coached you through it, but because your quality culture genuinely reflects GMP principles. That's the difference between compliance and excellence — and it's why Jared maintains a 100% first-time audit pass rate across more than 200 client engagements. Learn more about GMP certification requirements and what it takes to build a sustainable compliance program.