Our Services
We design and build AI-powered business systems for BioTech, Pharma, and Medical Device—such as QMS, clinical data platforms, regulatory assistants, pharmacovigilance tools, digital lab notebooks, and commercial insight engines—all fully compliant with FDA 21 CFR Part 11 to give your company a competitive edge.
AI-Powered Quality Management System (QMS)
​Automate deviation tracking, CAPAs, document control, and audit readiness using AI-driven insights to ensure continuous compliance and faster approvals.
AI-Driven Pharmacovigilance System
Monitor adverse event reports, social media, and literature in real-time using NLP and machine learning for early signal detection and global compliance.
Clinical Trial Data Intelligence Platform
Use generative AI to harmonize trial data, monitor patient recruitment, and generate real-time regulatory-ready reports, reducing delays and improving trial outcomes.
Digital Lab Notebook with AI Automation
Empower R&D teams with compliant ELNs that auto-summarize findings, suggest next steps, and integrate seamlessly with LIMS and instrument data.
Regulatory Submission Assistant
Streamline the preparation and submission of eCTD documents with AI that validates, formats, and cross-references data to reduce manual errors and accelerate approvals.
AI-Powered Commercial Insights Engine
Analyze sales, market access, and HCP engagement data using AI to uncover trends, optimize targeting, and personalize outreach strategies with compliance built in.
