Founder · Certify Consulting
Quality, regulatory and AI governance consultant
Jared Clark is the founder and principal consultant of Certify Consulting. He helps FDA-regulated manufacturers and ISO-certified companies build quality systems that hold up under audit, leads the firm's ISO/IEC 42001 work on AI governance, and builds production AI systems himself. He also runs Evata Consulting Group, his AI strategy and implementation practice.
"Keep it Simple. Keep it Real."
Background
Most AI consultants come from tech. Jared Clark comes from the regulatory side. He has spent his career on FDA liaison work, quality system design and regulatory affairs for companies that answer to an auditor or an FDA investigator, including pharmaceutical, dietary supplement, OTC drug, cosmetic and medical device manufacturers and organizations pursuing ISO certification.
He founded Certify Consulting in December 2016. The work runs the full length of a certification, from gap assessment and procedure writing through validation, internal and supplier audits, training, and the certification audit itself. He knows what auditors look for because he has been in the room with them, alongside NSF, UL, Intertek, SGS and ANAB-accredited registrars.
Since 2025 he has brought the same discipline to artificial intelligence. Jared builds and runs production AI systems every day, and he helps regulated companies govern the AI they already use. The question he brings to both is the one an auditor will eventually ask: when the model gets something wrong, who checked it, and where is the record?
"I build AI systems for companies where getting it wrong isn't an option."
That question is why ISO/IEC 42001 now sits at the center of the practice. ISO 42001 follows the same management-system structure as ISO 9001, ISO 13485 and ISO 27001, so a company that already runs one of those has much of what it needs. What is usually missing is the part specific to AI: knowing which AI is in use, assessing what it could get wrong, deciding where a person has to check its output, and keeping records that show the check happened. Jared's validation background carries over closely here, because most of the questions a reviewer asks about software turn out to be the questions worth asking about a model.
ISO 42001 and AI governance
ISO/IEC 42001 is the certifiable management-system standard for artificial intelligence. Certify Consulting helps companies that build or use AI put an AI management system in place and take it through certification, usually starting from the ISO or GMP system they already have.
Implementation and certification support, from setting the scope to the certification audit.
A fixed fee of $9,750. Where you stand against the standard and what closing the gaps will take.
A fixed fee of $5,000. For GMP, ISO 13485 and ISO 9001 sites where AI is already drafting records. In April 2026 FDA cited a drug manufacturer for releasing AI-written specifications and procedures without qualified review.
What ISO 42001 adds to a quality management system you already run.
Pharmaceuticals, dietary supplements, cosmetics and medical devices.
Answering customer AI questionnaires and building on ISO 27001 or SOC 2.
Also: ISO 42001 for R2 and ITAD facilities · What is ISO 42001?
Quality, GMP and FDA
Most engagements run from the first gap assessment to the day the certificate or the inspection report arrives, with the same consultant the whole way.
Quality systems for dietary supplement, OTC drug, pharmaceutical, cosmetic and food manufacturers, and preparation for FDA inspections.
ISO 9001, ISO 13485, ISO 14001, ISO 45001 and ISO 27001, on their own or as one integrated management system.
Process, cleaning, water system, equipment and computer system validation, using risk-based approaches such as GAMP 5 and computer software assurance.
Internal, supplier and pre-certification audits for GMP and ISO systems, so the findings arrive before the auditor's do.
SQF, BRC, FSSC 22000, HACCP and the other GFSI schemes.
R2v3 certification for electronics recyclers, and ITAR compliance for defense suppliers.
AI systems
The advice on governing AI comes from building and running it, which is where most of the hard questions show up first.
Jared is the architect of Nova QMS, an AI-powered quality management system in which document control, change control, CAPA and training work from the same records. Change an SOP and it finds every document that references it and opens the change requests, and it can check quality records against set criteria as they are created. People keep the judgment, and every action leaves an audit trail.
He built and runs an AI agent operating system that coordinates dozens of AI agents across several businesses, handling research, drafting, reporting and follow-up. Work that needs judgment is routed to a person and every action is logged, which is the same design he brings to client systems: agents take the repeatable work, and people keep the decisions.
His computer software assurance and pharmaceutical validation credentials apply directly to AI: what a model needs to be tested for, how much evidence is enough, and what the record should show when an FDA investigator or an ISO auditor asks.
Jared wrote two white papers published on Zenodo in 2025: Artificial Intelligence Exchange (AIX), a protocol for how AI agents hand work to one another, and The Process Protocol Layer (PPL), on AI that is transparent and auditable enough for regulated work.
Two practices, one consultant
GMP and FDA compliance, ISO certification, and ISO 42001. Start here if you need a certificate, an inspection you are ready for, or AI governance that has to fit inside a quality or management system you already run.
Contact Certify Consulting →Jared's AI practice. Start there if you want AI built into how your business runs: AI strategy and implementation on frontier models, with people kept in charge of the decisions once it is live.
Visit Evata Consulting Group →The same person does the work at both, so a project that starts at one can continue at the other without starting over.
Credentials
Each certification below links to the issuing body's own verification record, not to a page on this site. Check any of them.
American Society for Quality (ASQ)
Verify with ASQ →Regulatory Affairs Professionals Society (RAPS)
RAPS public profile →Certified 2019
Certificate available on requestEducation
Affiliations
Jared is also a member of the Utah State Bar on inactive status. He does not practice law, and Certify Consulting does not provide legal services.
Elsewhere
Records held by third parties, not by this site.
Whether the question is a GMP program, an FDA inspection, an ISO certificate, or the AI already writing records in your quality system, a consultation is a free 30 minutes with the person who would do the work.
Or email [email protected]