12-week CMC compilation cycles
That delay submission timelines and slow development
Manufacturing & CMC: Turn process data into CMC and Module 3 documents
Sanai drafts CTD Module 3 sections, process development and validation reports from your batch records and analytical data, with every value traced to its source record.
The challenge
Your manufacturing excellence shouldn't be limited by documentation capacity
You're building world-class manufacturing operations. But every hour your team spends manually compiling CMC documents is an hour not spent optimizing processes or scaling production.
The strategic reality: Your competitive advantage comes from manufacturing excellence, not from who can compile CMC sections fastest.
Data silos
Between manufacturing, quality, regulatory teams, CDMOs, and CROs
Tech transfer complexity
Documenting process transfers between internal sites and external partners
Tribal knowledge
Critical insights trapped with individual SMEs and partner organizations
Scale-up challenges
Documenting process changes across development phases and manufacturing sites
Quality system integration
Harmonizing documentation across multiple internal and external quality systems
AI CMC Module 3 authoring
Scale your best CMC expert across every process document
An AI system that understands the complexity of manufacturing processes in pharma and biotech and scales expert-level CMC documents across development phases
- Understands the complexity of pharma and biotech manufacturing processes
- Maintains institutional memory of process development history
- Scales expert-level CMC documents across development phases
- Integrates seamlessly with existing manufacturing and quality systems
- Writes to your templates, style guides and standards
Manufacturing-focused capabilities
Process characterization intelligence
from drug substance to drug product
Real-time process validation documentation against ICH guidelines
Cross-batch consistency tracking
maintains process narrative continuity
Multi-phase documentation
research through commercial scale
GMP traceability
full audit trail from data to document
Capabilities
AI for CMC regulatory writing
Intelligent process documents
Transform batch records, process parameters, and analytical data into Module 3 sections (3.2.S, 3.2.P) and the Quality Overall Summary (2.3) that follow ICH M4 organization and formatting standards.
Process validation integration
Automatically incorporate process validation data, critical process parameters, and proven acceptable ranges into your CMC narrative with proper scientific justification.
Cross-batch analysis
Track process consistency across development batches, scale-up studies, and validation runs. Generate trending analysis and process capability documentation.
Scale-up documents
Document process changes from development through commercial scale with clear rationale, risk assessments, and comparability protocols.
Analytical method integration
Seamlessly incorporate analytical method validation data, specifications, and control strategies into your overall CMC package.
Change control documents
Maintain comprehensive documentation of process changes, deviations, and continuous improvement initiatives with regulatory impact assessments.
Results
Real impact for manufacturing teams
Faster CMC compilation from 12 weeks to 3 weeks
Reduction in documentation collaboration time
More development programs with existing CMC resources
Why now
Every week of CMC delay costs your program
Manufacturing documentation bottlenecks cascade through your entire development timeline. While you're manually compiling CMC packages, competitors with streamlined documentation processes are advancing their programs faster.
Coverage
From lab scale to commercial manufacturing
Drug substance manufacturing
- Route of synthesis documentation
- Solvent recovery and recycling procedures
- Genotoxic impurity assessments
- Polymorphic form studies and controls
Drug product manufacturing
- Formulation development reports
- Container-closure system studies
- Dissolution method development and specifications
- Manufacturing process validation
Process development phases
- Research and early development
- Process characterization studies
- Scale-up and technology transfer
- Process validation and commercial manufacturing
Quality systems integration
- In-process controls and testing
- Environmental monitoring
- Equipment qualification
- Cleaning validation
Customers
Trusted by manufacturing leaders
Trusted by manufacturing executives at
- Fortune 500 pharma companies
- Leading biotech manufacturing organizations
- Contract development and manufacturing organizations (CDMOs)
“Version control used to be our biggest headache. Now we track every change automatically with complete impact analysis.”
“The AI understands our GxP language better than most junior staff. It's like having a GxP expert available 24/7.”
“Sanai Docs eliminated our document chaos. We now have complete visibility into our regulatory document landscape with full compliance confidence.”