AI SERVICES
40–50% Faster Submission Prep. 50% Medical Writing Time Reduction. eCTD v4.0 Ready
Maxis AI accelerates eCTD submission preparation 40 - 50%, cuts medical writing time 50%, and supports NDA/BLA readiness.
40–50%
Faster submission prep
50%
Medical writing time reduction
100%
First-pass validation target
3–6
Mo NDA/BLA prep vs. 6–12 mo
WHO IT IS
The Context
Maxis AI accelerates eCTD submission preparation 40 - 50%, cuts medical writing time 50%, and supports NDA/BLA readiness.
The challenge was not only content creation. Regulatory teams were managing manual document compilation, cross-referencing, technical validation, dossier assembly, and region-specific Module 1 requirements across multiple systems
With eCTD v4.0 transitions underway and global regulators moving toward evolving submission standards, the sponsor needed a governed AI-enabled execution model that could improve submission speed without compromising regulatory control, traceability, or expert oversight
Challenges
Key barriers to Regulatory Submission Execution
Manual Submission Preparation
- 6–12 month NDA/BLA preparation cycles
- Manual document compilation and assembly
- Cross-referencing burden across regulatory documents
eCTD Complexity
- Region-specific Module 1 variations
- Growing metadata and lifecycle management requirements
- Transition pressure from eCTD v3.2.2 to v4.0
Technical Rejection Risk
- Improper granularity
- Missing hyperlinks
- Metadata and validation errors causing costly resubmissions
Talent & Outsourcing Pressure
- 40–50% of regulatory submissions outsourced
- Shortage of experienced eCTD specialists
- High dependency on senior regulatory publishing resources
Operational solution
Maxis AI agentic workflows — under human oversight throughout
Automated eCTD Assembly
- AI-assisted CTD package compilation
- Module 1–5 organization
- Region-specific formatting
Outcome
40–50% faster submission prep
Regulatory Document Intelligence
- AI-generated safety narratives
- CSR content generation
- Protocol-aware document drafting
Outcome
50% medical writing time reduction
Technical Validation & Publishing Support
- Pre-submission conformance checks
- Automated hyperlinking
- Validation workflow support
Outcome
100% first-pass validation target
Maxis AI operates as a governed and supervised execution layer within existing systems throughout.
See it across your submission workflows
Curious how this could improve your submission readiness?
We'll review your submission workflow, identify operational bottlenecks, and show where governed AI workflows can accelerate submission readiness in a 30-minute working session.
Measured impact
Quantified outcomes after deploying Maxis AI's agentic workflows
| Metric | Before Maxis AI | After Maxis AI |
|---|---|---|
| Submission Prep | 6–12 month NDA/BLA prep | 3–6 month AI-assisted prep |
| Submission Assembly | Manual CTD assembly | 40–50% faster eCTD prep |
| Medical Writing | Manual drafting and cross-referencing | 50% less writing time |
| Technical Validation | Validation and metadata errors | First-pass validation target |
| Dossier Management | Fragmented submission workflows | Unified AI-enabled workflow |
Outcome
Quantified Benefits
The sponsor shifted from manual, fragmented submission preparation to a supervised AI-enabled regulatory submission lifecycle from document generation to eCTD publishing.
Submission preparation accelerated by 40–50%
Medical writing time reduced by 50% through AI-assisted regulatory document generation
NDA/BLA preparation compressed from 6–12 months to 3–6 months
First-pass validation target supported through pre-submission conformance checks and governed eCTD workflows
Explore our AI Workforce Platform
See how AI agents are transforming study startup, data management, oversight, and regulatory submissions.