AI-native platform for regulatory documentationSource data to a review-ready
submission in hours, not months.

Sanai is an AI-native regulatory and medical writing platform for pharma, biotech and medical device teams. It turns raw data from the lab, clean room and clinic into cited regulatory filings, clinical documents and SOPs, with every claim verified by your reviewers and kept on one FDA 21 CFR Part 11 record.

Sanai is purpose built for regulatory documentation in life sciences, to overcome the shortcomings of frontier platforms. That includes a proprietary database of best practices that optimizes performance for life sciences, best-in-class human-in-the-loop review, immutable audit logs for compliance traceability, custom document automation workflows for your entire organization, and premium service to customize the platform to your organization's needs. Together, these features give you the fastest time to value of any platform on the market without sacrificing quality.

Regulatory filings, clinical documents such as protocols and clinical study reports, CMC and quality documents, and SOPs. Drafts are produced in your format and writing style, in Microsoft Word.

No. Sanai connects to the systems your data already lives in, such as electronic lab notebooks, LIMS, quality and regulatory systems, and keeps every passage linked to its source. Your data comes in through Sanai's proprietary ETL pipeline, which enriches the metadata and establishes key relationships, so our agents retrieve the most relevant data exactly when it's needed.

Yes. Sanai provides the technical controls Part 11 requires: electronic signatures, secure audit trails, complete document lineage and version control, and role-based access with single sign-on and multi-factor authentication. Sanai is SOC 2 Type II and supports your team's own system validation.

No. Sanai does not train on your data. You keep control and visibility of all your content, which is encrypted with AES-256 at rest and in transit.

Regulatory, clinical science, medical writing, CMC, quality and medical affairs teams at pharmaceutical, biotech and medical device companies, and the CDMOs, CROs and consulting firms that support them.

Sanai keeps evidence, drafts, review decisions and sign-off on one verified record. Every claim links to its source, an evaluator agent checks every claim before your experts sign off, and versions and Part 11 e-signatures are built in, so the audit trail builds itself as the work moves. Template Builder then turns approved documents into automations for the next program.

In live deployments, teams see 95–99% less time to first draft, review and approval cycles 50% faster, and about 360 hours returned per person each year. Drafts were accepted 94% of the time, against 60% for the next best platform, head to head at a top-10 pharma company.

Yes. Sanai already works with consulting firms alongside pharma, biotech and medical device teams. Send us a message through our contact page to talk about a partnership.

Sanai connects to electronic lab notebooks like Benchling, LIMS, quality management and regulatory information systems such as Veeva Vault, and document stores like SharePoint. Anything else can connect through Sanai's REST API and webhooks.

Yes. Sanai drafts to FDA, EMA, PMDA and ICH requirements, and documents carry over between regulators with minor adjustments.