Pharma combines valuable confidential data, validated systems and regulators who are writing their AI expectations now. That makes it hard to show that AI is under control, and it is why we position this offering with Life Sciences in mind. ANG Associates comes from Life Sciences and IT delivery, so we can work with R&D, Quality, IT and the board in one conversation.
Jan 2026
EMA and FDA published ten guiding principles of good AI practice in drug development, covering the medicine lifecycle from early research and clinical trials to manufacturing and safety monitoring. They are broad guidance, not binding law.
EMA news release, 14 January 2026
The Kiteworks figure is cross-industry, vendor-run and from 2025, so we read it as a signal. Regulatory status changes; please verify against the EMA and your own regulatory team before relying on any of it.
AI Exposure Check
Where do R&D, clinical and process data meet AI tools?
Discovery data, trial data, formulations and process know-how are the assets. We map where they reach public or unapproved AI tools, and which vendor terms and retention settings apply to them.
AI Audit Readiness
Can we show auditors and inspectors how our AI is controlled?
We prepare the evidence pack: AI inventory, intended use, risk classification, validation and change control records, monitoring and human oversight. This follows the direction of the EMA and FDA principles and draft Annex 22. We prepare you; we do not certify.
Agent Access Review
What can AI agents reach inside validated and regulated systems?
We review agent identities, permissions and logging around systems such as document management, quality, laboratory and ERP platforms, and how agent actions fit your data integrity and change control expectations.
Safe Fast-Track
Which AI use cases can go live now, and which need more control?
We sort your portfolio of use cases by risk, for example literature review, drafting support, deviation triage or commercial content. Low-risk cases move with guardrails; GxP-critical ones get the validation they need before they go live.
AI Coverage Gap Review
Do our policies respond when AI touches quality or safety decisions?
We prepare the questions and the AI use picture that your broker needs to review product liability, cyber and professional liability cover. We are not a broker and give no coverage opinions.
Sovereign Path
Where may our data and models live, and who can access them?
For clinical and patient-related data and cross-border transfers, we compare hosting and model options in Switzerland and the EU, and prepare the questions for your legal counsel and data protection officer.