Zelthy Regulatory Affairs Reviews & Product Details

Zelthy Regulatory Affairs is an AI-powered regulatory authoring workspace for pharmaceutical and biotech companies preparing FDA and EMA dossier submissions. It provides a unified document library where regulatory teams import source documents — Clinical Study Reports (CSRs), CDISC datasets (SDTM, ADaM), Tables, Listings and Figures (TLFs), Investigator Brochures, and Protocols, and use AI to author synthesis documents including CTD Module 2 summaries (2.5 Clinical Overview, 2.7 Clinical Summaries), US Prescribing Information (USPI), FDA correspondence, and Integrated Summaries of Safety and Efficacy (ISS, ISE). Key features and functionalities Zelthy Draft ships with four AI agents operating across the full dossier lifecycle: - a Dossier Consistency Agent that reads all imported documents simultaneously and flags discrepancies in efficacy data, safety data, subject counts, and dosing information across CSRs, summaries, and labelling; - a Gap Analysis Agent that maps the assembled dossier against FDA and EMA guidance requirements, identifies missing data sections, and surfaces unanswered regulatory questions before they become FDA queries; - an AI Drafting Agent that authors first drafts of Module 2 summaries, USPI, and FDA correspondence grounded entirely in the imported source evidence, with every AI-generated claim linked back to the source document and page number; - and a Regulatory Intelligence Agent that monitors FDA and EMA guidance updates, tracks precedent decisions on similar molecules, and surfaces relevant intelligence during the authoring process. The full document library is AI-searchable and cross-referenceable, with collaborative review workflows, document version control, eCTD structure and formatting support, and a complete audit trail on all AI-generated content. Primary value and solution provided Regulatory dossier authoring is one of the most time-consuming and error-prone activities in pharmaceutical drug development. A typical CTD Module 2 submission involves synthesising hundreds of pages across dozens of source documents, and a single data inconsistency or missed regulatory requirement can trigger a Complete Response Letter that delays approval by 12 months or more. Zelthy Draft reduces both the time and the risk. The Consistency Agent catches cross-document discrepancies that human reviewers routinely miss when working under deadline pressure. The Gap Analysis Agent identifies submission-readiness issues weeks before the filing date rather than days before. And the AI Drafting Agent, which produces citation-traced first drafts grounded in imported evidence rather than generating unsupported text, reduces Module 2 authoring time by 60–70%, giving small regulatory teams the throughput to compete with larger organisations without proportionally larger headcount.