Months-long submission cycles
That slow time-to-clinic and delay market entry
AI for Regulatory Submissions: Turn your source data into review‑ready regulatory submissions
IND and BLA sections with a traceable line from every claim to its source.
Multiple sites. Endless versions. Changing regulations. Sanai brings order to the chaos, automatically integrating regulatory data, managing submission documents, and checking each section against current FDA, EMA, PMDA and ICH guidance.
- ✓IND, NDA, BLA and 510(k) sections
- ✓Every claim traced to its source
- ✓Part 11 e-signatures and audit trails
The challenge
Your pipeline shouldn't wait on regulatory writing
You're leading breakthrough science at companies that matter. But every day your teams spend on manual document assembly is a day not spent on the next therapeutic advance.
The strategic reality: Your competitive advantage comes not from having the most data, but from making the most of your data.
Cross-functional information bottlenecks
Between R&D, Regulatory, and Quality teams
Data rich, insight poor
Valuable insights trapped within your data
Capability drain
Institutional knowledge walking out with SME turnover
Scalability limits
Great teams can't clone themselves
AI regulatory writing software
Scale your best regulatory mind across every submission
An AI system that understands the nuances of your therapeutic area and scales expert-level document creation across teams
- Understands the nuances of your therapeutic area
- Maintains institutional memory and best practices
- Scales expert-level document creation across teams
- Integrates seamlessly with your existing data infrastructure
- Learns from your organization's submission history
From data to filing
- Study data
- Batch records
- Nonclinical
- Labeling
Module 1 · Admin
Module 2 · Summaries
Module 3 · Quality
Module 4 · Nonclinical
Module 5 · Clinical
Submission readiness
ConsistentAudit trail
- FDA
- EMA
- PMDA
- Health Canada
Strategic capabilities
Therapeutic area specialization
custom-configured for any therapeutic area, from oncology to rare diseases
Checks against current FDA, EMA and ICH guidance
Cross-reference intelligence
maintains consistency across modules
Multi-agency formatting
FDA, EMA, PMDA, Health Canada ready
Audit-ready traceability
full provenance from data to document
Capabilities
From source data to review-ready sections
Automated document classification
Automatically sort, categorize and tag regulatory documents saving hours of manual work. Ingest, analyze, and classify documents per your preferences for easy retrieval.
Intelligent Document Assembly
Point our AI at your data, select your submission type (IND, NDA, BLA, 510(k)), and watch it build well-structured documents that follow standard regulatory formats.
Submission readiness checks
Every section is reviewed against relevant FDA, EMA, and ICH guidelines for completeness, so your experts start from a checked draft.
Label generation and compliance
Generate product labels and compare them against applicable regulatory standards, highlighting and flagging any inconsistencies for correction.
Agency-specific formatting
Adapt content to each agency, from eCTD structure to header styles, and translate it for global submissions.
Document Quality Enhancement
Create well-organized, clearly written documents with proper navigation and logical flow to support your regulatory strategy.
Results
Real impact for regulatory teams
Faster document preparation from 6 months to 6 weeks
Reduction in cross-functional coordination overhead
More document projects with existing headcount
Fewer revision cycles with better initial drafts
Why now
Every day costs you $2M
That's the average daily cost of a delayed drug launch.¹ While you're manually formatting regulatory documents, competitors with smarter document preparation processes are getting to submission faster.
¹ Based on industry analysis of pharmaceutical launch delays and revenue impact. Source: Deloitte Center for Health Solutions, "Measuring the return from pharmaceutical innovation" and McKinsey & Company pharmaceutical launch excellence studies.
Coverage
IND, NDA and BLA drafting, and every other route to market
FDA submissions
- IND (Investigational New Drug)
- NDA (New Drug Application)
- BLA (Biologics License Application)
- 510(k) Premarket Notifications
- PMA (Premarket Approval)
International submissions
- EMA (European Medicines Agency)
- Health Canada
- PMDA (Japan)
- TGA (Australia)
- NMPA (China)
Specialized pathways
- Breakthrough Therapy Designation
- Fast Track Applications
- Orphan Drug Designations
- Emergency Use Authorizations
What Sanai drafts, by module
- Module 1: Administrative Information
- Module 2: Common Technical Document Summaries
- Module 3: Quality (CMC)
- Module 4: Nonclinical Study Reports
- Module 5: Clinical Study Reports
Customers
Trusted by industry leaders
Trusted by executives at
- Fortune 500 pharmaceutical companies
- Leading biotech organizations
- Contract research and manufacturing organizations
“The AI catches regulatory compliance issues that would typically take weeks of review to identify. It's a game-changer for our team.”
“The automated compliance checking has prevented multiple submission delays. It's like having a regulatory expert reviewing every document.”
“Finding the right data used to take hours. Now I get precise results in seconds, with full context about where the information came from.”