FDA submissions take months of manual assembly. Batch records are reviewed page by page. Deviation reports require pulling data from 6 different systems. DxLogic builds AI workflows that automate the documentation burden — so your scientists focus on science and your regulatory team focuses on strategy.
Find Your Workflow →Purpose-built automation for specialty pharma, generic manufacturers, CMOs, and emerging biotech teams.
AI compiles IND, NDA, and ANDA submission packages — pulling from clinical data, CMC documentation, labeling, and prior correspondence. Cross-references against FDA format requirements and flags gaps before submission. Your regulatory team reviews a complete draft instead of building from scratch.
AI extracts data from batch records — ingredient quantities, process parameters, in-process testing results, deviations — and populates quality systems automatically. No more manual transcription from paper batch records to electronic systems.
AI processes adverse event reports from multiple sources — MedWatch, clinical trials, literature, customer complaints — classifies severity, identifies signals, and generates regulatory filings. Safety signals detected faster, reporting deadlines never missed.
AI monitors FDA guidances, EMA updates, ICH guidelines, and pharmacovigilance requirements. Maps changes to your current filings and SOPs, generates impact assessments, and tracks implementation deadlines. Your regulatory team knows what changed and what to do about it — without reading 500 pages of Federal Register.
AI drafts SOPs from templates and prior versions, tracks review cycles, manages version control, and ensures consistency across manufacturing sites. Annual reviews that took weeks happen in days.
AI consolidates data from LIMS, ERP, QMS, and clinical databases into unified dashboards. Batch yield, stability data, clinical enrollment, and supply chain status — all visible in real-time without manual spreadsheet builds.
How pharmaceutical companies eliminated manual bottlenecks and saw measurable ROI.
If any of these describe your day-to-day, we built this for you.
Your regulatory team is your bottleneck. AI handles the document assembly and monitoring so your CMC and regulatory scientists focus on strategy and science.
Every client has different batch record formats, quality requirements, and regulatory submissions. AI handles the variability across clients so your quality team scales without proportional headcount growth.
You have a small regulatory team doing the work of a large one. AI gives your 3-person team the output capacity of a 10-person team without the overhead.
Book a free 30-minute AI Assessment. We’ll map your regulatory and quality workflows, identify where manual documentation is consuming your team, 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.