SyncIQ

SyncIQ is an AI-powered platform built for regulatory professionals in the pharmaceutical industry, designed to accelerate, automate, and enhance the process of authoring and reviewing CMC (Chemistry, Manufacturing, and Controls) dossiers for drug approvals. By ingesting and analyzing source documents (like BMRs, COAs, and stability reports), SyncIQ generates structured, compliant drafts for Module 2 and Module 3 of CTD submissions, ensures traceability, flags inconsistencies automatically, and guides users through extraction, drafting, compliance critique, and refinement—saving significant time while improving quality and compliance.