Solutions · Pharma/Biotech
eCTD Module 1-5 Blueprints™
Produce FDA-aligned INDs, NDAs, and BLAs faster — without sacrificing rigor or control.
INDs & IND amendments
NDAs / BLAs (partial or full)
Clinical Study Reports (CSRs)
Investigator Brochures (IBs)
Quality Overall Summaries (QOS)
Nonclinical & clinical summaries
Regulatory briefing documents
Health Authority responses & supplements
What AI makes possible
Novo Nordisk reduces Clinical Study Report authoring from ~50 FTEs to approximately 3 “super users”.
AI handles the grind.
You focus on science.
Structured drafting, validation, and iteration across all eCTD modules:
Module 1 — regional administrative content, including IB
Module 2 — quality, nonclinical, and clinical summaries
Module 3 — CMC documentation
Module 4 — nonclinical study reports
Module 5 — clinical study reports and supporting documents
Evidence organization & cross-linking
Automatically structures and links source data, summaries, and references—reducing manual cross-checks and reconciliation across modules.
Narrative consistency
Applies a coherent, regulator-aligned structure across documents so summaries, data, and conclusions stay in sync.
Early gap identification
Surfaces missing inputs or inconsistencies early—before they become late-stage review issues or authority questions.
Lifecycle-ready updates
Enables efficient updates as programs expand, studies are added, or CMC information changes—without starting from scratch.
AI-powered SERVICES
Need an expert?
We can help.
Use a regulatory specialist from our partner network to create and finalize your document.
