AI-Powered Solutions
Built by Real Pharmaceutical ExperiencePharmaceutical Manufacturing, Science & Technology
Every week the FDA posts new Warning Letters. We read them all and write up the few that matter for a plant like yours — with tools and actionable items for your team, so you can verify you are not at risk of the same violations reported in these public documents. A direct link to every source document is included.
A new issue every week — we check every line by hand before it goes out. Free to read; no account needed.
Free to read and run — no account needed. Independent — not affiliated with the FDA.
Tools built for the floor.
Made for drug manufacturers — across every dosage form, from tablets and capsules to injectables, topicals, and liquids.
AI agents for manufacturing
Imagine the future of pharmaceutical manufacturing. A world where efficiency, quality, safety, workforce development and financial reporting are powered by Artificial-intelligence (AI) agents. PharmTech.AI brings over 25 years of real pharmaceutical manufacturing experience from the shop floor to site leadership. Let's partner and see how we can build a customized AI-powered agent that solves your unique challenges. See what one of our agents produces in the link below.
Each week, our Warning Letter Brief agent sorts new FDA warning letters into whichever categories apply:
Drugs & Biologics · Food · Medical Devices · Tobacco · Veterinary · Cosmetics · Other Programs
Simulation software
Software that puts your leaders and managers through a realistic decision while nothing is at stake — so they practice the hard calls before they face them for real. Do your managers know how to respond to crises, conflict or problems in the event you are not accessible? Our simulations are customized for your needs and challenge your people leaders on how to respond. Better yet, you can receive a report on strengths and opportunities for coaching. Try our Wildfire simulation demo concept in the link below.
The wildfire drill is live to try now — see a sample after-action report. Inspection, recall, and supply-loss scenarios are in development.
Custom builds
When nothing off the shelf fits, we design an agent or a simulation around your site's own pain points — working with you, in person or online. We'll start by defining the Inputs, Outputs, Controls and Mechanisms upfront in order to ensure alignment to your goals. Let's build it! Contact our team to schedule a free consultation by emailing info@pharmtech.ai today!
Fixed scope and price, agreed on a short call before any work starts: see what's included →
Everything here is for training and decision-support. A person reviews every output, and nothing writes into your regulated GxP (good practice) records. Your inputs are never used to train any model, and your own quality system stays the system of record. Every tool ships with a plain statement of what it does and doesn't do — a Computer Software Assurance (CSA) context-of-use statement you can hand to your validation team.
PharmTech.AI is built on real hands-on experience in pharmaceutical manufacturing. Technical experts, Scientists and People Leaders with real factory experience. We have first-hand experience in leading teams through crisis management, resolving supply-chain issues, and leading teams through the most challenging FDA inspections. That experience — and a hard-won habit of adapting when the plan breaks — is why we built PharmTech.AI, part of Aligned Executive Solutions, Inc.
Our weekly Warning Letter Brief is not to highlight the company, but rather to learn from what is happening in the industry and intended as a preventive tool. It provides clear actionable preventive actions that any FDA-regulated company can take today to ensure they have controls in place to prevent such issues. Every week we read the FDA warning letters that posted, write up the few that actually matter for a plant like yours, and check every line by hand — with a direct link to each source document. It's free to read, and you don't need an account.
We embrace the use of AI (Artificial Intelligence) while being honest that there is much work to do to bridge the gap. From Operational Efficiency to Manufacturing Science and Technology, our mission is to build customized AI solutions that meet your needs.
What we believe in
People First
Safety, Quality, Talent Selection, Talent Development
Process
Strong systems across all business units in pharmaceutical manufacturing
Product
Continuous innovation, stress-tested process development, and robust, reproducible manufacturing processes that deliver consistent, high-quality products
We use real situations + lessons learned + logic + AI to build customized solutions around your business.
Two things you can run right now.
Both are free, both are finished, and neither needs an account. Read one, run the other, and see what these tools actually produce before anyone talks to you about a project.
The Warning Letter Brief
An AI agent reads every FDA warning letter posted that week, sorts them, and writes up the few that matter for a plant like yours. We check every line by hand before it goes out.
- Floor-check ideas you can hand a supervisor on Monday
- A direct link to every FDA source document, so you can verify it yourself
- A new issue every week — free to read, no account needed
The wildfire readiness drill
A wildfire forces a shutdown at a fictional plant. You make the calls under a clock, and the drill shows you where they landed. Nothing you type is stored, and nothing is used to train any model.
- An after-action read-out with strengths and coaching points
- Built from a real plant shutdown, not an invented scenario
- A demonstration — it assesses no one and goes in no record
The same thing, pointed at your floor
An agent that reads your deviations the way this one reads warning letters. A drill written on your own site's emergency plan. A read-out that tells you which supervisors need coaching, and on what.
- Built around one real problem, with you, in person or online
- Fixed scope and price, agreed on a short call before any work starts
- Across every dosage form — tablets, capsules, injectables, topicals, liquids
Inspection, recall, and supply-loss drills aren't built yet, and neither are the prompt packs. If you want one of them first, say which — it moves up the list.
Build it with us.
When nothing off the shelf fits, we build a custom AI agent or simulation around one real problem on your floor — or run a facilitated session for your team. Across every dosage form. Priced per engagement, scoped on a short call.
What you get
- A custom agent or simulation built around one real problem — not a generic tool
- Or a facilitated session that puts your leaders through the hard calls before they're real
- Built with you, in person or online, with a fixed scope and price agreed up front
- A CSA context-of-use statement your validation team can use — on every build
- Your security review completed before any data changes hands
Questions worth asking.
Is this affiliated with the FDA?
No. PharmTech.AI is an independent service of Aligned Executive Solutions, Inc. and is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration. It is educational and is not legal, regulatory, or compliance advice.
What's free here?
The weekly Warning Letter Brief — an operator's read on new FDA Warning Letters: which few matter this week, what to check on your own floor, and gemba-walk ideas (a simple "go and see" walk of the actual work). Every issue is free to read on the resources page. The wildfire readiness drill is live — run it free. Prompt packs are in build. No account and no credit card needed.
Is it safe to bring into a regulated operation?
Yes — that's the point of the design. Every tool comes with a plain statement of what it does and, just as important, what it does not do (a Computer Software Assurance, or CSA, context-of-use statement). It is for training and decision-support only; a person reviews every output, and it never writes to or constitutes a GxP (good practice) record. Your inputs are never used to train any model, and we complete your security review before any data changes hands. We publish a CSA validation rationale you can hand straight to your validation team.
What happens when I ask for a custom build?
A short call with us — no pressure. We look at your site's pain points together, agree on what to build (an agent, a simulation, or a facilitated session for your team), and put a fixed scope and price on it. We work with you in person or online. If it isn't a fit, we'll tell you.