The RegulatoryIntelligence Accelerator speeds up regulatory submissions by automatically generating CTD/CMC documentation from validated manufacturing and quality data, in ICH M4Q-aligned structure and language.
Manufacturing, quality, and analytical data must be manually consolidated into submission-ready CMC documentation. Four issues slow this process down.
The accelerator turns validated process and quality data directly into submission-ready, ICH-aligned regulatory content.
Auto-generates CTD/CMC sections (Modules 2 and3) from process and quality data, reducing dependency on manual compilation and formatting.
Summarises batch, stability, and analytical data into concise regulatory language aligned with agency expectations.
Dafts specific sections such as 3.2.S.2.2 Manufacturing Process or 3.2.P.5 Control of Drug Product from standardized process descriptions and control strategies.
Ensures ICH M4Q-compliant structure and consistent language across every product filing.
Regulatory affairs and CMC teams that need to compile manufacturing and quality data into submission-ready dossiers faster, without sacrificing compliance.
No. It automates first-draft generation and formatting; regulatory writers and subject-matter experts still review, refine, and approve every section before filing.
Draft CTD/CMC sections (Modules 2 and 3), including manufacturing process and drug product control narratives, built from validated process and quality data.
Every generated section follows the ICH M4Q structure and language conventions, and is traceable back to the underlying manufacturing and quality data.
