Jared Clark — FDA Regulatory Consultant

Jared Clark

FDA Regulatory Consultant

RAC JD MBA PMP CPGP CFSQA CMQ-OE
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About Jared Clark — FDA Regulatory Expert

Jared Clark is the founder of Certify Consulting, a full-service certification consulting firm serving manufacturers, healthcare companies, technology firms, and food producers across the United States. With credentials including JD, MBA, PMP, CMQ-OE, CPGP, CFSQA, and RAC, Jared brings a unique combination of legal, business, regulatory, and technical expertise to every engagement. The FDA Expert is a specialized practice within the Certify Consulting network, focused exclusively on FDA regulatory consulting across all product categories — drugs, medical devices, food, dietary supplements, and cosmetics.

What sets Jared apart in the FDA consulting landscape is the breadth and depth of his regulatory knowledge. Most FDA consultants specialize in a single product category — devices only, or drugs only. Jared's practice spans the full scope of FDA jurisdiction, from CDER-regulated pharmaceuticals and CDRH-regulated medical devices to CFSAN-regulated food facilities and dietary supplement manufacturers. This cross-category expertise is particularly valuable for companies whose product portfolios touch multiple FDA centers, or for manufacturers entering new FDA-regulated markets for the first time.

With over 200 clients served and a 100% first-time audit pass rate, Jared has built a track record that reflects both technical precision and practical business sense. His clients range from early-stage startups navigating their first FDA registration to established manufacturers facing FDA warning letters and enforcement actions that threaten their ability to operate. In every case, the approach is the same: understand the regulatory requirements, build a clear compliance roadmap, and execute with discipline.

Professional Credentials

A rare combination of legal, business, quality, and regulatory certifications — each directly relevant to FDA compliance and regulatory affairs.

RAC
RAPS

Regulatory Affairs Certification

The gold standard credential in pharmaceutical and medical device regulatory affairs. Issued by the Regulatory Affairs Professionals Society (RAPS), the RAC demonstrates mastery of FDA regulatory frameworks, submission pathways, and compliance strategy. Jared holds the Pharmaceuticals specialty designation.

CPGP
ASQ

Certified Pharmaceutical GMP Professional

Validates deep expertise in FDA Current Good Manufacturing Practice (CGMP) regulations for pharmaceutical manufacturing. Covers 21 CFR Parts 210 and 211, process validation, quality control testing, production controls, and facility compliance — the foundation of every FDA inspection.

CFSQA
ASQ

Certified Food Safety & Quality Auditor

Demonstrates auditing competence across food safety management systems including FSMA, HACCP, HARPC, and 21 CFR 111 (dietary supplement CGMP). Essential for FDA-regulated food facilities, supplement manufacturers, and companies subject to CFSAN oversight.

CMQ-OE
ASQ

Certified Manager of Quality/Organizational Excellence

Covers the full spectrum of quality management — strategic planning, management systems, quality methodologies, leadership, and organizational excellence. Provides the systems-level thinking required to build FDA-compliant quality management systems from the ground up.

JD
Degree

Juris Doctor

Legal training provides a critical edge in FDA regulatory work. Understanding enforcement mechanisms, consent decrees, administrative law, and compliance defense strategies means Jared approaches regulatory challenges with both technical precision and legal awareness.

MBA
PMP

MBA & Project Management Professional

Business strategy and project management discipline ensure every FDA engagement is structured, on-time, and aligned with your commercial goals. Regulatory compliance is only valuable if it enables your business — not just satisfies an auditor.

FDA Compliance Experience

A career built on helping companies navigate the most complex regulatory environment in the world.

Pharmaceutical & Drug Consulting

Jared has guided pharmaceutical companies through CGMP compliance under 21 CFR Parts 210 and 211, ANDA and NDA submission strategy, facility design qualification, process validation, and FDA inspection readiness. His RAC and CPGP credentials reflect direct, tested expertise in the regulatory frameworks that govern every aspect of drug manufacturing and distribution in the United States. Whether a company is launching a new over-the-counter product or responding to CDER enforcement action, Jared provides the regulatory clarity needed to move forward with confidence.

Medical Device Consulting

From Class I exempt devices to Class III PMA submissions, Jared has supported device manufacturers through the full spectrum of CDRH regulatory requirements. His 510(k) consulting practice covers predicate device analysis, performance testing strategy, submission preparation, and pre-submission (Q-Sub) meetings with FDA. He has helped companies establish and maintain quality management systems under FDA's Quality Management System Regulation (QMSR) and the new alignment with ISO 13485, ensuring their design controls, production processes, and post-market surveillance programs satisfy both FDA and international expectations.

Food, Dietary Supplement & Cosmetics Consulting

Jared's CFSQA certification underpins his work with food manufacturers, dietary supplement companies, and cosmetics producers navigating CFSAN regulations. His food safety consulting covers FSMA compliance, Preventive Controls for Human Food, HARPC plan development, and FDA facility registration under 21 CFR Part 1. For dietary supplement manufacturers, he provides CGMP compliance consulting under 21 CFR Part 111, label claim substantiation, adverse event reporting systems, and FDA inspection preparation. His MoCRA compliance work helps cosmetics manufacturers meet the latest FDA registration and safety substantiation requirements.

Enforcement Response & Remediation

When companies receive FDA warning letters, Form 483 observations, import alerts, or consent decree threats, the response must be fast, precise, and credible. Jared's legal training (JD) combined with his regulatory expertise means he understands both the technical requirements and the enforcement dynamics at play. He has helped companies develop strategic responses that satisfy FDA concerns while protecting business continuity, and has built remediation programs that address root causes rather than just surface-level findings. His approach turns enforcement actions into opportunities to build stronger, more sustainable compliance systems.

A Practical Approach
to FDA Compliance

FDA regulatory compliance should be a business enabler, not a bureaucratic obstacle. Jared's consulting philosophy is grounded in practical, actionable guidance that gets companies to compliance efficiently — without unnecessary complexity or inflated timelines.

Every engagement begins with a thorough regulatory assessment to understand where you stand and what it will take to get where you need to be. From there, Jared develops a clear roadmap with defined milestones, realistic timelines, and fixed-fee pricing so you always know what to expect. There are no surprises — just structured, disciplined regulatory work delivered by someone who has done it hundreds of times.

Whether you are a startup bringing your first product to an FDA-regulated market, an established manufacturer preparing for a routine inspection, or a company in crisis responding to an enforcement action — the same principles apply: understand the requirement, build the system, execute with precision, and document everything.

Schedule Free Consultation (858) 240-4353

Cross-Category FDA Expertise

Drugs, devices, food, supplements, cosmetics — all five FDA-regulated product categories under one practice.

Legal + Regulatory + Business Perspective

JD, MBA, and RAC — three lenses that most consultants don't have, applied to every engagement.

200+ Clients, 100% First-Time Pass Rate

A track record built on disciplined preparation and thorough compliance systems, not luck.

Fixed-Fee, Structured Engagements

Clear scoping, defined milestones, and transparent pricing. You know exactly what you're getting and what it costs.

Part of the Certify Consulting Network

Access to a broader network of ISO, quality, and compliance expertise through Certify Consulting.

Ready to Work with an FDA Expert?

Schedule a free consultation with Jared Clark, RAC, CPGP, CFSQA. Whether you need help with FDA registration, inspection preparation, 510(k) submissions, or warning letter remediation — let's build a compliance strategy that works.

Schedule Free Consultation (858) 240-4353