Effective date: August 9, 2026 · Last updated: August 28, 2026
Change note (August 28, 2026): section 7 now expressly allows short attributed quotes and a personal reference copy, and bars using our content to train AI models; section 8 clarifies that search-engine and AI-assistant reading of our public pages stays welcome. Changes apply from posting, per section 15.
These Terms of Use ("Terms") are an agreement between you and Aligned Executive Solutions, Inc. ("we," "us"), the operator of the PharmTech.AI website and the free tools, demonstrations, publications, and accounts offered on it (the "Services"). By accessing or using the Services, you agree to these Terms. If you do not agree, do not use the Services. The Services are intended for business professionals; they are not directed to children under 16, and you must be at least 18 to create an account. Paid work — a pilot, a custom build, or a facilitated session — is governed by its own signed written agreement, not by these Terms (see section 9).
The Services currently include: The Warning Letter Brief, a free weekly publication about newly posted FDA warning letters, based on public FDA records with links to each source document; a free readiness drill; free interactive demonstrations and prototypes (for example, a study designer, an equipment-protocol walkthrough, a batch-record authoring prototype, and a governance-board walkthrough); free accounts; and pages where you can ask us about custom work. Some tools are labeled a "demo," "concept demo," "prototype," or "demonstration sample" — those labels mean what they say: the tool or document is illustrative, may contain placeholder content, and does not represent a completed, validated, or expert-approved work product.
Everything in the Services is provided for education, training, rehearsal, and decision-support purposes only. The Services are not legal, regulatory, or compliance advice; not a gap assessment or audit of any facility; and they do not guarantee any inspection, regulatory, or business outcome. Using the Services does not create any professional, consulting, or advisory relationship. The Services do not write to, and their output does not constitute, any GxP or other regulated record — your own quality system remains your system of record, and a qualified person on your side must review anything from the Services before it informs a real decision. You are solely responsible for your own quality, regulatory, and business decisions.
Parts of the Services are produced with artificial intelligence or are simulations, and are labeled as such where they appear. AI-generated and simulated content can be incomplete, outdated, or simply wrong, even when it reads as confident. Do not rely on it without independently verifying it against the source documents, your own data, and your own experts. Where the Services link to FDA documents, the FDA's published record — not our summary of it — is the authoritative source.
PharmTech.AI is independent and is not affiliated with, endorsed by, or sponsored by the U.S. Food and Drug Administration or any government agency. References to FDA documents are references to public records.
Accounts are free and sign-in is passwordless: we email you a one-time link that expires in 15 minutes, and using it starts a session of about 30 days. You agree to provide an email address you control and to keep that mailbox secure — anyone who can read your email can use your sign-in links, so treat access to that mailbox as access to your account. Accounts are for you; do not share sign-in links. You can sign out, export your data, or delete your account at any time from the account page — deletion is immediate and self-service. We may suspend or close an account that violates these Terms or that we reasonably believe is being used abusively; where practical we will tell you why.
Some tools (the readiness drill and the study designer) save your working entries in your browser's local storage on your device, and the batch-record prototype keeps your entries only in the open page until you export them; none of those entries are transmitted to us. That also means we cannot back them up or recover them — closing or reloading the page can discard unexported entries, clearing your browser's site data deletes locally saved work, and we make no promise that on-device work will be preserved. We do not use what you send us to train AI models. Anything you do send us through a form or by email (for example, a question about custom work) is handled as described in our Privacy Policy, and you give us permission to use it to respond to you and to operate the Services. You are responsible for what you submit: do not send us anything unlawful, anything that infringes someone else's rights, or anyone's confidential information — the site's forms are not a confidential channel, and no confidentiality obligation exists unless we have signed an agreement that creates one.
We grant you a limited, non-exclusive, non-transferable, revocable license to access and use the Services for your internal business and educational purposes. All content, software, trademarks, and materials in the Services are owned by us or our licensors, except that FDA warning letters and other government documents we link to or summarize are in the public domain. You may not resell, redistribute, or republish the Services or their content, use them to build a competing product, or remove any notice or label from them, without our written permission. Quoting a short excerpt publicly, with attribution and a link back to the source, is fine and needs no permission. A single copy kept for your own reference — the kind that gets pinned to a break-room corkboard — is fine; a mirrored or reposted copy of a page is not. The license above does not include using content from the Services to train or fine-tune a machine-learning or artificial-intelligence model, or as training data for one, and we reserve our rights in our content for text and data mining wherever the law allows such a reservation. Output you generate with a tool for your own internal use (for example, a draft study protocol or drill read-out) is yours to use internally, subject to sections 2 and 3. If you send us feedback or suggestions, we may use them without obligation to you.
You agree not to: use the Services in violation of any law or third-party right; interfere with or disrupt their operation; probe, bypass, or overload their security or rate-limiting measures; scrape or bulk-download content by automated means (search-engine indexing of public pages is fine); misrepresent tool output as validated, expert-approved, or FDA-endorsed; or use another person's account. Automated reading and indexing of our public pages so that search engines and AI assistants can find us, answer questions about us, and cite or link back to us is fine; copying our pages wholesale, or collecting our content to train an AI model, is not (see section 7). We may investigate and act on violations, including blocking access.
These Terms govern the free, public Services. Any paid engagement — a pilot, a custom agent or simulation, or a facilitated session — happens only under a separate written agreement signed by both sides, which governs that work (including confidentiality, data handling, and payment). If a signed agreement conflicts with these Terms, the signed agreement controls for that engagement. Nothing on this site is an offer that becomes a contract by itself; scope and price are agreed in writing before work starts.
The Services link to third-party sites (for example, FDA.gov) and are delivered using third-party providers (for example, our hosting and email-delivery providers, described in the Privacy Policy and Cookie Notice). Optional browser features some tools can use — such as your browser's built-in voice dictation — are provided by your browser vendor under its own terms. We are not responsible for third-party sites or services.
The Services are provided "as is" and "as available," without warranties of any kind, express or implied — including merchantability, fitness for a particular purpose, accuracy, and non-infringement — to the fullest extent permitted by law. We do not promise that the Services will be uninterrupted, error-free, or secure, or that any content is complete or current. Some jurisdictions do not allow the exclusion of certain warranties, so parts of this section may not apply to you.
To the fullest extent permitted by law: we will not be liable for any indirect, incidental, special, consequential, or punitive damages, or for lost profits, lost data (including on-device tool entries), or business interruption, arising from or relating to the Services; and our total liability for all claims relating to the Services will not exceed US $100. Some jurisdictions do not allow certain limitations of liability, so parts of this section may not apply to you; in that case our liability is limited to the smallest amount the law allows. Nothing in these Terms limits liability that cannot be limited by law.
You can stop using the Services at any time, and you can delete your account yourself from the account page. We may suspend or end access to the Services (or any part of them) for violations of these Terms, to protect the Services or their users, or because we discontinue a feature. Sections 2, 3, 6, 7, 11, 12, 14, and 15 survive any termination.
These Terms are governed by the laws of the State of California, without regard to its conflict-of-laws rules. Before filing any claim, contact us at info@pharmtech.ai — most concerns can be resolved quickly and informally. Any dispute that cannot be resolved informally will be brought exclusively in the state or federal courts located in California, and both sides consent to that jurisdiction and venue.
We may update these Terms as the Services change; the revised version will be posted here with a new "Last updated" date. For material changes we will give conspicuous notice — a notice on the site and, if you have an account, an email — and changes apply prospectively from posting; your use of the Services after that means the updated Terms apply to you. If you do not agree to a change, stop using the Services and, if you have an account, delete it. These Terms are the entire agreement between you and us about the free Services (paid engagements have their own agreements). If part of these Terms is found unenforceable, the rest stays in effect. Our not enforcing a provision is not a waiver of it. You may not assign these Terms; we may assign them as part of a reorganization, merger, or sale of the business.
Aligned Executive Solutions, Inc.
info@pharmtech.ai
Postal address available on request.