For biotech and life sciences

Your data is the company: sequences, assay results, structures, ELN entries, trial data, models and regulatory submissions. Your scientists want AI on all of it. Your board, partners and regulators want to know that none of it leaks, and that every record can be trusted.

What we build for biotech

Confidential AI on proprietary science. Run LLMs and domain models over lab notebooks, protocols, literature and internal reports, either on your own GPUs or inside attested confidential-computing enclaves. No model provider sees your prompts or documents, and you can verify it.

Secure collaboration with partners and CROs. Confidential data "clean rooms" let a pharma partner, CRO or academic group run agreed analyses on your data (or you on theirs) without either side seeing the raw data. Attestation proves which analysis code ran.

Protecting models and IP. Model weights and proprietary pipelines are served from enclaves with attestation-gated key release. A copied disk or snapshot is useless.

Audit trails that stand up to inspection. Immutable logs give you tamper-evident, time-stamped records of who did what, when, and with which system version. That maps directly to 21 CFR Part 11 §11.10(e) audit-trail expectations and to data-integrity principles (ALCOA+).

Workflows that remove the busywork:

Drafting regulatory and quality documents (deviation reports, CAPAs, SOP updates) from your own records, for human sign-off
Literature and patent monitoring summarized for your programs
Instrument and LIMS data pipelines with provenance from instrument to report
Sample, inventory and vendor paperwork processed automatically

Compliance we design for

21 CFR Part 11 and EU GMP Annex 11: electronic records, signatures and audit trails. We support your computerized-system validation (GAMP 5-style) with specs, test evidence and traceability.
HIPAA where you handle PHI, and GDPR for EU trial participants and data transfers
GxP data integrity (ALCOA+), SOC 2 and ISO 27001 readiness for partner due diligence
Data residency for multi-country trials: data stays in the region your protocol and consent require

Your QA and regulatory teams own validation and compliance decisions. We supply the systems, controls and evidence.

The offer

Sovereignty Audit, from $14,500. We map where your scientific and patient data flows, which AI and SaaS vendors can see it, your TCB and your Part 11 and HIPAA gaps, then deliver a fixed-price roadmap.
Build, from $9,500 per build week. Your first confidential AI workflow or clean room, usually in 1 to 4 weeks. You own the code and the keys.
Managed, from $2,500 / month. We run it with continuous attestation monitoring and 7-year log retention on the Assured plan.

Book a free call to talk through your data and your partners.