From $750/month

Managed AI for FDA-regulated manufacturers

Certify
Managed AI

Your team using AI the right way, every month, without hiring an AI person. We set AI up to work with your own procedures and records, train your people on it, and keep it working as the tools change, for one flat monthly fee.

"Keep it Simple. Keep it Real."

Book a Free Call 858-240-4353

From $750/month

Published price

4 weeks

To set up

Monthly

Retainer

Jared Clark, Certify Managed AI consultant

The Problem

The problem we hear every week

Most of your people are already using AI, usually on their own, with no rules and no idea where your documents end up. Nobody owns it, so it never gets past writing emails. Meanwhile, your quality team is still buried in deviations, supplier questionnaires, complaint write-ups, and audit prep, which is exactly the kind of paperwork AI handles well when it is set up properly.

Hiring someone to own AI is expensive, and hard to justify for a company your size. A one-time project helps for a few months, until the tools change and nobody is left to fix them. So we become the people responsible for making AI work in your business, and you pay a monthly fee, the same way you pay for IT support.

The First Month

Set it up right

Your documents, ready for AI

We organize your procedures, batch records, specifications, and supplier files so AI gives answers from your system, not from the internet. This is the step most AI projects skip, and it is why many of them fail.

Three to five tasks that pay off

For example, drafting deviation and complaint investigations, answering supplier and customer questionnaires, preparing for audits, summarizing batch records, and answering routine customer email.

Your AI rules and basic protections

A short, plain staff AI policy: what people may use, what they may never paste in, and who reviews what AI drafts. We also put the basic protections in place, so your AI accounts are locked down and your team knows how to spot the scams AI now makes easy, like a cloned voice asking for a payment.

Training on your own work

Hands-on sessions using your documents and your tasks, not generic slides.

Every Month After That

Keep it working and keep it growing

We keep every task working as the AI tools change, and fix anything that breaks.
We add a new task each month, chosen with you.
We keep your documents current, so AI answers stay accurate when procedures change.
We watch for new AI risks aimed at companies like yours, and keep your protections current.
Your staff can ask us questions whenever they get stuck.
A short monthly meeting with you: what got used, how much time it saved, and what comes next.

Built For Regulated Work

AI drafts, and a qualified person approves

AI in an FDA-regulated plant is different from AI in a marketing agency. Every task we set up keeps a clear line between what AI drafts and what a qualified person reviews and approves, so nothing AI writes becomes a GMP record without someone signing off. We also keep track of which tasks touch your quality records, so your validation and data-integrity story holds up in an audit.

You also decide where your data lives. Tasks run through business accounts whose terms say they do not train on your data, through accounts you already have, or, on the Plus plan, on a private server that keeps everything in-house.

Price And Terms

From $750 per month, with a one-time setup fee

Three plans, set by the size of your team. AI software subscriptions are billed at cost, or you use the accounts you already have. Month to month after the first three months.

Starter

For teams of up to 15 people

$750 / month

$1,500 one-time setup

Three AI tasks set up
Staff AI policy and basic AI protections
One training session
One new task every quarter
Monthly check-in

Standard

For teams of 15 to 50 people

$1,500 / month

$2,500 one-time setup

Five AI tasks set up
Your documents made ready for AI
Staff AI policy, basic AI protections, and training
One new task every month
Monthly check-in and usage report

Plus

For teams of 50 to 100 people

$2,500 / month

$4,000 one-time setup

Everything in Standard
AI assistants for each department
Option to keep AI on your own private server
An audit-ready record of every AI task
Priority response

How It Starts

Three steps

A 30-minute call

You tell us where the paperwork piles up, and we tell you honestly whether AI can help with it.

A one-page proposal

Within 48 hours, naming the first tasks and the plan that fits your team.

Setup in about four weeks

Then the monthly service begins, and it grows one task at a time.

A good fit

You make dietary supplements, cosmetics, OTC drugs, or food, and your quality team is stretched.
Your people use AI on their own and you want rules, training, and real results from it.
You want AI help with quality paperwork without hiring a full-time AI person.

Not the right service

–You want AI to approve batches or sign records on its own. We will not set that up.
–You need a large custom software build. That is a project, not this service.

Frequently asked questions

What does Certify Managed AI cost?

There are three plans, set by the size of your team. Starter, for up to 15 people, is $750 per month with a $1,500 setup fee. Standard, for 15 to 50 people, is $1,500 per month with a $2,500 setup fee. Plus, for 50 to 100 people, is $2,500 per month with a $4,000 setup fee. AI software subscriptions are billed at cost, or you use accounts you already have. After the first three months, every plan runs month to month.

Do our documents go to an AI company?

Only through business accounts whose terms say they do not train on your data, or, on the Plus plan, a private server that keeps everything in-house. We set this up first, before anyone pastes anything.

Will AI write our GMP records?

It drafts them. A qualified person on your team reviews and approves every one. That rule is built into how each task is set up, so nothing AI writes becomes a GMP record without a person signing off.

Does this cover security?

It covers the AI side of it. We lock down the AI accounts your team uses, set rules for what may be shared with AI, and teach your people to recognize AI-driven scams, such as cloned voices and fake invoices. It is a sound starting point. If you need a full security program, we will tell you so and help you find the right partner.

We already tried ChatGPT. Why is this different?

On its own, it does not know your procedures, your products, or your customers. We connect it to your own documents, pick the tasks where it pays off, and stay around to keep it working.

What if we want to stop?

After the first three months it is month to month. Everything we set up stays yours: the tasks, the policy, and the organized documents.

Do you also help with ISO 42001?

Yes. If a customer asks you to prove you manage AI responsibly, the policy and records from this service are a head start, and we can take you the rest of the way to ISO/IEC 42001.

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, founded Certify Consulting in 2016, and builds production AI systems for regulated companies. He holds the PECB ISO/IEC 42001 Lead Implementer certification, the ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), and Certified Pharmaceutical GMP Professional (CPGP) certifications, and Biopharma Institute professional certifications in Computer System Validation (CSV) and Computer Software Assurance (CSA). His full credentials and their verification links are on the About page.

Coming To This Service

Nova, our quality management software, in development

We are building Nova, quality management software designed around the same rule: AI helps with everything, and on the judgments that matter, your people think first and the record shows they did. Document control comes first, because most small manufacturers we work with do not have a document system they are happy with, and AI is only as good as the documents behind it.

Nova is being designed to connect to the document storage you already use, so AI has the full picture from day one, whether your documents move into Nova or stay where they are. As each part of Nova becomes ready, Managed AI clients are offered it first. Nova is not available yet, and the service does not depend on it.