Terms of use

This website, pharmasynapse.ai, is operated by Brainy Neurals Private Limited, an AI engineering company incorporated in India on 23 November 2023. These terms apply to everyone who uses the site. By continuing to read it you accept them; if you do not, the remedy is straightforward — stop using the site.

These terms govern the website: the pages, the published material, and the one form on the homepage. They do not govern an evaluation, an early-access engagement, or a deployment of PharmaSynapse. Each of those happens under a written agreement signed by both parties, and where a written agreement exists, it prevails over this page.

Nothing on this website creates a supplier relationship, a licence to the software, or an obligation on either side to engage. Submitting the early-access form is a request, not an agreement, and we are equally free to say no.

Who owns it

Everything published on this website — text, page designs, document renders and diagrams — belongs to Brainy Neurals unless attributed to someone else. The regulatory texts we cite, 21 CFR and the EU GMP chapters and annexes among them, belong to their issuing authorities. We quote them and cite them; we do not claim them.

What you may do without asking

Read it, print it, quote it with attribution, link to it, and circulate it inside your organisation. None of this needs our permission and none of it requires an email address: nothing on this site is gated and there is no download behind a form.

What needs a conversation first

Republishing whole pages, offering the material commercially, or presenting it as your own work. Write to us first — where attribution travels with the content, the answer is usually yes.

PharmaSynapse and Brainy Neurals are our names and marks. Use them to refer to us accurately. Do not use them to suggest an endorsement, partnership or affiliation that does not exist, and do not use them in a way that implies we have validated, certified or approved anything of yours.

The material published here — the source-document summaries, the writing on GMP batch documentation, everything on the resources page — is general information, written from practitioner experience and from the regulations it cites.

It is not regulatory, legal or consulting advice on your facility, your product or your submission. Our reading of a clause is our reading of it. Your quality unit owns your decisions, and nothing on this website substitutes for its judgement or for advice from a qualified professional who knows your operation.

We check regulatory citations against their sources before publishing and we carry the status date in the text. Where a source is in draft, the page says draft. Neither of those makes the material advice.

PharmaSynapse runs in deployed environments under written agreements. No formula, bill of materials or batch data passes through this website, and nothing you read here grants access to, or a licence for, the software itself.

Descriptions of what the product does are descriptions, not commitments, and they change as the product does. Where a page describes intended behaviour, the binding version of that description is the one in a signed agreement, not the one on a marketing page.

An evaluation, an early-access engagement or a deployment is governed by its own signed agreement covering confidentiality, document handling, data, service levels and liability. These terms do not attempt to do that work, and where the two differ, the signed agreement wins.

This matters more here than on most websites. A supplier-qualification reviewer needs to know which document binds us, and the answer is never this one.

Acceptable use

Do not misuse the site: no attempts to break it or probe it, no impersonating us, no unlawful use.

Automated access for reading, indexing and answering questions is welcome. We allow AI crawlers deliberately, because a QA professional asking a language model about a clause deserves an accurate answer and we would rather it came from a source that cites the regulation. Reading at scale is fine; misrepresenting what you read is not.

The form, and what not to put in it

Do not send confidential material through the form on this website — not a master formula, not a batch record, not anything your document control would restrict. Controlled documents change hands only under a written agreement with a defined handling procedure. That is the only way we take custody of them, and it protects you rather than us.

Links to other sites

We link to regulators, standards bodies and the sources we cite. Those sites are theirs — their content, their terms. A link is a citation, not an endorsement of everything at the destination.

We work to keep this website accurate, and regulatory citations are checked against their sources before publication. It is nonetheless provided as it is, without a warranty that it is complete, current or free of errors.

Pages change as the product and the regulatory landscape do. One of the sources this site relies on is a draft that has not been finalised; where that is the case the page says so and carries a status date, and the date is the thing to check.

To the extent the law allows, we are not liable for loss arising from use of this website or from reliance on its content. Nothing here excludes liability that cannot lawfully be excluded, including for fraud or for death or personal injury caused by negligence.

Decisions about your records, your batches and your submissions remain, as they should, with your quality unit.

These terms are governed by the laws of India, and disputes belong to the courts of Ahmedabad, Gujarat.

When these terms change, the new version is published here with a new effective date. Earlier versions are available on request — we do not overwrite our own record, on this page or in the product.