BLA packages with thousands of documents. Clinical trial master files across multiple studies. Batch records requiring cell line traceability across manufacturing sites. FDA, EMA, and ICH requirements evolving faster than your quality team can track. DxLogic builds AI workflows that automate the regulatory and quality overhead — so your teams focus on bringing therapies to market, not assembling paperwork.
Book Your AI Assessment →Purpose-built automation for biologics manufacturers, biosimilar developers, cell & gene therapy companies, and CDMOs.
AI assembles and validates BLA, IND, and sCTD submission packages — cross-referencing thousands of documents against FDA, EMA, and ICH requirements. Tracks module completeness, flags missing sections, and generates submission-ready indices. Your regulatory affairs team reviews complete packages instead of assembling them from scratch.
AI maintains Trial Master Files across multiple studies and sites. Ingests investigator documents, ethics approvals, monitoring reports, and protocol amendments. Cross-references against DIA TMF Reference Model. Flags completeness gaps before inspections, not during them.
AI tracks deviations, CAPAs, change controls, and OOS investigations across your entire quality system. Cross-references events against batch records and regulatory commitments. Identifies trending issues before they become systemic. GxP-compliant audit trails on every action.
AI reviews batch records for cell line traceability, raw material verification, in-process controls, and release specifications. Cross-references against master batch records and validated parameters. Flags deviations in real-time during production — not days later during manual review.
AI manages supplier qualification packages, audit schedules, and compliance documentation across your entire supply chain. Tracks certificates of analysis, GMP audit results, and regulatory status for every critical material supplier. Flags expiring qualifications 30-60-90 days out.
AI processes adverse event reports, ICSRs, and periodic safety reports across post-market and clinical trial operations. Cross-references MedDRA coding, validates E2B formatting, and tracks submission deadlines to regulatory authorities. Ensures expedited reports meet 15-day and 7-day timelines.
How biotech enterprises eliminated regulatory bottlenecks and saw measurable ROI.
If any of these describe your organization, we built this for you.
Multiple products in various stages of development and commercialization. BLA submissions, post-market commitments, and manufacturing operations generating thousands of quality documents per month. AI unifies regulatory, quality, and manufacturing data — giving leadership real-time visibility across the entire product lifecycle.
BPCIA pathways, analytical similarity packages, and novel therapy designations creating regulatory complexity that compounds with every product in your pipeline. AI manages the documentation burden across FDA, EMA, and multi-jurisdiction filings so your regulatory team focuses on strategy, not assembly.
Dozens of client programs running simultaneously across multiple manufacturing suites. Each client with different quality agreements, batch record formats, and regulatory requirements. AI standardizes documentation workflows across programs while maintaining client-specific compliance requirements.
Book a free 30-minute AI Assessment. We’ll map your highest-volume regulatory and quality workflows, identify where manual processes are costing you millions in overhead and submission delays, and show you the 3 workflows with the highest ROI.
First workflow live in 60 days. Cancel the retainer with 30 days notice. No lock-in.