On site · Accountable

Hands-On Quality and Regulatory Work

The work that needs
a person in the room

AI can draft a procedure. It cannot walk a supplier's floor, sit in the back room during an FDA inspection, or sign an audit report and stand behind it. These are the services where an experienced, accountable person makes the difference.

"Keep it Simple. Keep it Real."

Book a Free Call 858-240-4353
8
Services
On site
Across the US
Prices
Published
Jared Clark, The work that needs a person in the room consultant

Services

Choose the one that fits the problem

Each one is a fixed fee, quoted in writing after a free 30-minute call. If you are not sure which you need, start with the call.

Supplier Audits

On-site audits of your contract manufacturers and ingredient suppliers, with a signed report for your supplier file.

Internal Audits

An independent, qualified auditor runs your internal audit program so findings arrive before your registrar's.

Mock FDA Inspection

We inspect your site the way FDA would and give you a mock Form 483 while there is time to fix it.

FDA Inspection Readiness and Support

Ready before FDA arrives, and an experienced hand in your back room while the investigator is there.

FDA Remote Regulatory Assessments

Help answering an FDA records request or remote assessment, and closing the gaps it exposes.

Form 483 and Warning Letter Response

A Form 483 or warning letter response with real root causes and evidence, inside 15 business days.

OTC Drug GMP

Drug GMP under 21 CFR 210/211 for cosmetic and personal care makers moving into OTC products.

Fractional Quality Executive

A part-time senior quality and regulatory leader with regular site days, on a monthly retainer.

Prices

What each service costs

Published prices, confirmed in writing before any work starts. Travel for on-site work is billed at cost, with no markup.

ServicePriceWhat the price includes
Supplier AuditsFrom $3,500 per audit, plus travelOne day on site, preparation, the signed report within a week, and review of the supplier's corrective actions
Internal AuditsFrom $1,600 per audit dayAudit planning, the audit on site or remote, the written report within a week, and verification of corrective actions
Mock FDA Inspection$6,000 to $12,000Preparation and document request, one to three days on site, a mock Form 483 and the written report within a week
FDA Inspection Readiness and Support$2,000 per day during an inspection; readiness quoted as a fixed feeBack-room support, document review and daily debriefs for as long as FDA is on site
FDA Remote Regulatory AssessmentsFrom $3,500, quoted the same dayA read of the request, the organized records package and cover letter, and a gap list with a plan to close it
Form 483 and Warning Letter Response483 response from $5,000; warning letter response from $12,000Triage of each observation, root-cause support, the response drafted for your signature with evidence indexed
OTC Drug GMPGap assessment $8,500 fixed; later phases quotedTwo days on site against 21 CFR 210/211, benchmarked to NSF/ANSI 455-4, with a written report and phased plan
Fractional Quality ExecutiveFrom $7,500 per monthAn agreed number of hours each month, scheduled site days and a monthly report to leadership

Your Consultant

Who does the work

Jared Clark, our principal consultant, leads every engagement. He has spent his career in quality systems, FDA liaison work and regulatory affairs for pharmaceutical, dietary supplement, OTC drug, cosmetic and medical device manufacturers, and founded Certify Consulting in 2016. He holds the ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE) and Certified Pharmaceutical GMP Professional (CPGP) certifications, and has worked through certification and surveillance audits alongside NSF, UL, Intertek, SGS and ANAB-accredited registrars. His full credentials and their verification links are on the About page.

Not sure which you need?

Book a free 30-minute call. Describe the problem and we will tell you which service fits, or whether you need one at all.

Book a Free Call Call 858-240-4353

Or email us at support@certify.consulting