The Challenge
A late-stage biotech preparing its first New Drug Application (NDA) faced significant delays in compiling and formatting the required documents — particularly clinical summaries, module narratives, and cross-referencing safety data across multiple studies.
Their key pain points included:
- Manually written CTD modules causing long lead times
- Duplicate effort across teams writing similar safety and efficacy sections
- Inconsistency in tone, structure, and source citations
- Lack of real-time validation for cross-document accuracy
- Pressure to meet internal timelines without sacrificing compliance
Our Solution
Agile Genix deployed a domain-trained Natural Language Processing (NLP) engine to automate the drafting and quality check of regulatory documents — aligned with ICH and FDA formats.
✅ Document Structuring Models
Fine-tuned NLP models to auto-assemble document skeletons for CTD Module 2 and Module 5 — including headings, summaries, and linked data fields.
✅ Medical Writing Augmentation
Deployed AI models trained on clinical trial protocols, CSR outputs, and historical submission templates — generating first drafts in seconds.
✅ Semantic Cross-Linking Engine
Enabled auto-validation of data references across efficacy and safety sections — ensuring consistency in adverse events, population subsets, and outcomes.
✅ Human-in-the-Loop Workflow
Medical writers reviewed AI-generated drafts via a secure interface — editing and commenting in real-time with full version control.
✅ Compliance Alignment
Documents were output in eCTD-ready XML and PDF formats, aligned with FDA’s Technical Rejection Criteria and ICH M4 standards.
Impact Delivered
- 65% reduction in time to draft Module 2 summaries
- 90% reduction in manual errors and duplicate content
- Achieved internal submission milestones 3 weeks ahead of schedule
- Maintained full traceability for audit trail and version control
- Increased confidence from regulatory affairs and sponsor review teams
Want to Explore AI for Regulatory Submissions?
From summaries to signals, AI is redefining how documentation gets done. Agile Genix helps life sciences organizations integrate intelligent automation across the entire regulatory pipeline.
Request an AI Demo for Regulatory Automation
Let’s show you what our domain-trained NLP models can do for your documentation timelines.