AI-Powered Writing: Document Authoring

Filings and SOPs drafted in your format and style, in Microsoft Word.

Generate standard GxP documents with one click.

Each section drafted in 5 to 10 minutes
Your formatting and writing style
Every claim cited

How it works

From your sources to a cited first draft

Document Authoring drafts each section from the documents you attach, in your template, and flags what the sources don't support. Your experts review and sign off.

Pick a template and invite authors and reviewers to the same draft
Attach source documents to the whole draft or to one section
Generate the sections you choose while evaluation agents flag data gaps
Missing data is marked in red, never invented, so the draft is ready for review

Features

Intelligent regulatory authoring

AI-powered writing that understands regulatory requirements, scientific terminology, and your organization's standards.

Iterative Content Generation

Multi-pass content generation with progressive refinement, contextual awareness that improves with each iteration, and integration of user feedback into subsequent generations.

Comprehensive document coverage

Generate SOPs, batch manufacturing records, clinical documentation, and regulatory submissions with automated fact-checking against source data and regulatory requirements.

Real-time collaboration

Enterprise-grade collaboration with simultaneous multi-user editing, role-based permissions, threaded discussions, and integration with enterprise authentication systems.

Section-Level AI Regeneration

Granular control with individual section regeneration, multiple generation options with comparative analysis, and style adjustment for different audiences.

Custom template engine

Organization-specific customization with custom templates, preferred terminology integration, and dynamic template selection based on regulatory requirements.

Quality assurance and validation

Content accuracy verification with automatic cross-referencing, citation generation, consistency checking, and 21 CFR Part 11 compliance with electronic signatures.

See it on your documents

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Coverage

Every document type, drafted from your sources

Comprehensive authoring capabilities covering all regulatory document requirements across the submission lifecycle.

Clinical documents

Clinical Study Reports (CSRs)
Clinical Protocols and Amendments
Investigator's Brochures (IBs)
Clinical Overviews and Summaries

Regulatory submissions

IND Applications
NDA/BLA Modules
Common Technical Documents
Regulatory Correspondence

Safety documents

Development Safety Update Reports
Periodic Safety Update Reports
Risk Management Plans
Clinical Safety Reports

Quality documents

CMC Sections (Module 3)
Manufacturing Information
Quality Specifications
Analytical Method Validation

Enterprise Integration

Works with the tools your team already uses

Sanai connects to Word, SharePoint, Veeva, Benchling and the rest of your stack, so there is no data migration.

Microsoft Word
Google Drive
SharePoint
Dropbox
Box
OneDrive
Google Docs
Microsoft Teams
Slack
Jira
Confluence
Okta
Microsoft Entra ID
Google Workspace
Snowflake
Databricks
Amazon S3

Veeva Vault
Benchling
LabWare LIMS
MasterControl
ODOpenText Documentum
STSparta TrackWise
LabVantage
IDBS
Thermo Fisher SampleManager
Medidata Rave
Oracle Clinical One
RREDCap
Veeva CTMS
PubMed
EEndNote
Zotero

Results

Accelerate your document creation

See immediate improvements in document quality, compliance, and team productivity.

65%

Reduction in regulatory submission preparation time

80%

Faster manufacturing SOP development

85%

Improvement in document accuracy and completeness

30%

Decrease in document review cycles

Trusted by medical and technical writers

“Automated Authoring understands our regulatory language better than most medical writers. It's like having a senior writer available 24/7.”

Head of Regulatory WritingGlobal pharmaceutical company

“We've cut our CSR writing time by 80% while actually improving quality and consistency across our submission documents.”

Senior Medical WriterClinical research organization

“The AI catches regulatory compliance issues that would typically take weeks of review to identify. It's a game-changer for our team.”

Regulatory Affairs DirectorBiotech company

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Solutions

Built for every team

Each team in life sciences has unique workflows. Sanai adapts to your specific needs across medical writing, regulatory affairs, manufacturing, and more.

IND and BLA sections with a traceable line
from every claim to its source.

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