Healthcare & Life Sciences

AI for life sciences is software that reads, drafts and checks the documents behind drug, biologic and device work: protocols, study reports, submission modules, labels, batch records, deviations and promotional claims. The useful kind cites the exact source of every value and leaves the decision to a qualified person. Botminds offers 129 such solutions for life sciences, across research, clinical, regulatory, medical, manufacturing and quality, commercial and market access.

AI drafts submission content such as CTD Module 2 summaries and answers to health authority questions from the dossier and past approved answers, with a citation for every number. It can also track agency changes and find every local label that a core data sheet change affects. A regulatory lead reviews and signs every output. Botminds offers solutions for each of these tasks.

No software is compliant on its own. Compliance comes from how a system is validated and used for its intended purpose, under your quality system. Look for an audit log that cannot be altered, named electronic sign-off, role-based access, and a risk-based validation approach such as the one the FDA set out for medical device makers in its Computer Software Assurance guidance (final, February 2026). Botminds provides immutable audit logging of every human and agent action, SSO, role-based access and a qualified person's sign-off on every decision that matters.

In January 2026 the EMA and the FDA jointly published ten guiding principles for good AI practice in drug development. They cover a risk-based approach, adherence to GxP, a clear context of use, data governance, performance assessment and life-cycle management. In January 2025 the FDA also issued a draft guidance with a risk-based framework for judging whether an AI model is credible when its output supports a regulatory decision.

Annex 22 is a proposed new annex to the EU GMP guidelines on the use of artificial intelligence in medicine manufacturing. The European Commission consulted on the draft, prepared by EMA inspectors with PIC/S, from July to October 2025, together with a revised Annex 11 on computerised systems and a revised Chapter 4 on documentation. It was still a draft in October 2026, so manufacturers apply the existing computerised-system rules and follow the direction of the draft.

AI drafts protocol sections in the sponsor's approved template, and drafts results sections from the statistical tables, linking each number to its table cell. Writers then edit and verify a cited draft instead of building it by hand. Botminds offers clinical protocol authoring, clinical study report authoring and medical writing quality control, which checks each report number against its source table.

Yes, as a drafting and checking aid, with QA making the decision. AI can show reviewers only the batch record entries that break a rule. For a deviation, it can gather the batch, equipment and room logs for the event window and propose a root cause with the evidence for and against it. Botminds offers batch record review by exception and deviation and CAPA management, and QA reviews and signs each output.

With Botminds, no: your inputs and outputs are not used to train models. Ask every vendor this question and get the answer in the contract, because unpublished trial data, GxP records and commercial terms are among a company's most sensitive information.

Many regulated companies need this. Botminds runs as multi-tenant SaaS, in a dedicated cloud environment or fully on-premises, with the same controls in each. Those controls are TLS in transit, AES-256 at rest, isolation per customer and an audit log that cannot be altered.

It depends on the approach. Custom builds and point tools often need months of integration and validation work before the first output. Botminds builds a solution from your specification and deploys it as part of the build, once its functional and non-functional quality gates pass, so a pilot measures working software on your own documents. Plan your validation time separately, according to your quality system.