Operator-built AI for drug manufacturers

Artificial intelligence built for pharma manufacturing — by someone who ran the plant.

Start free with the Warning Letter Brief — a weekly operator's read on new FDA warning letters, and what to check on your own floor. From there, add AI agents that make your plant leaner and simulations that train your leaders. All from 25 years of real plant calls.

Free account — no credit card, unsubscribe anytime.

What we build

Tools built for the floor.

Made for drug manufacturers — across every dosage form, from tablets to injectables.

AI agents for manufacturing

Artificial-intelligence (AI) agents that find waste, delay, and cost in how your plant runs — the Lean Six Sigma work of doing more with less. The point is a leaner, healthier operation that lasts.

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.

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. Facilitated sessions for your team live here too.

Everything here is for training and decision-support. A person reviews every output, and nothing writes into your regulated GxP (good practice) records. Every tool ships with a plain statement of what it does and doesn't do — a CSA context-of-use statement you can hand to your validation team.

How to start

Start free. Grow when you're ready.

One path, three steps — from a free account to a tool we build with you.

Step 1

Free account

$0

  • The weekly Warning Letter Brief (see a sample)
  • Free prompt packs
  • Demo simulations to run
Create your free account
Opening soon Step 2

Build your own

$149/month

  • Advanced prompt packs for agents and simulations
  • Build your own AI tools, no code required
  • Cheaper than hiring us — you build it yourself
Join the waitlist
Step 3

Custom, with us

Let's talk

  • A custom agent or simulation for your site
  • Facilitated sessions for your team
  • In person or online
Talk to Mike
Mike Pulido, founder of PharmTech.AI
Why trust these tools
For 25 years I made the real calls in oral-solid-dose manufacturing — inspections, quality holds, a plant I shut down ahead of a wildfire. PharmTech turns that into tools your team uses every week. Your leaders get to practice the hard calls before they are real.
Mike Pulido · Founder, PharmTech.AI · 25 years in oral-solid-dose operations and quality · a service of Aligned Executive Solutions, Inc.
Frequently asked questions (FAQ)

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 do I get with a free account?

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). You also get free prompt packs and demo simulations you can run. No credit card.

What is the $149 per month plan?

It is the self-serve middle step. You get advanced prompt packs for building your own artificial-intelligence agents and simulations — cheaper than hiring us, and you build it yourself. It is opening soon; join the waitlist and we will tell you when it is ready.

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 the founder, Mike — no pressure. We look at your site's pain points, 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.