Best Of Your Growth, Our Mission
Accelerate Discovery. Automate Compliance. Optimize Outcomes.
In today’s life sciences landscape, the race to innovate is defined by speed, precision, and regulatory alignment. Agile Genix enables organizations across pharma, biotech, CROs, and healthcare to harness the full potential of AI and intelligent automation — not as a buzzword, but as a measurable business advantage.
Our solutions embed AI across the research, regulatory, and operational value chain — driving efficiency, enhancing data accuracy, and unlocking insights that were previously invisible.
OUR WORK
Where We Bring Intelligence to Life
We deliver AI solutions that are purpose-built for regulated environments and backed by deep domain expertise.
🧠 AI for R&D and Drug Discovery
- Predictive modeling for compound efficacy and safety
- ML algorithms for target identification and validation
- Natural language processing (NLP) for literature mining
- Computer vision in preclinical imaging analysis
Outcome: Reduced R&D cycle time, faster go/no-go decisions, and data-driven development.
📜 Regulatory Automation
- NLP-based document extraction and classification
- Automated assembly of CTD/eCTD submissions
- AI-driven deviation and CAPA management
- Intelligent quality assurance in GxP environments
Outcome: Lower human error, faster submission cycles, and real-time regulatory readiness
🧾 Clinical Operations Optimization
- Patient eligibility modeling and trial recruitment prediction
- Anomaly detection in eCRF data and site reporting
- Intelligent protocol deviation alerts
- Forecasting for trial resource utilization
Outcome: Improved patient recruitment, fewer protocol violations, and faster trials.
🧬 Pharmacovigilance Automation
- Signal detection and case prioritization using machine learning
- Automated narrative generation and case triage
- Integration with E2B-compliant safety systems
- Real-world evidence (RWE) signal mining from EMRs and social data
Outcome: Scalable adverse event processing with reduced manual effort and improved compliance.
Platform & Stack Expertise
We build and deploy AI/ML systems using robust and compliant infrastructure:
- Frameworks: TensorFlow, PyTorch, Scikit-Learn, spaCy
- Languages: Python, R, Java
- Platforms: AWS SageMaker, Azure ML, GCP Vertex AI
- Compliance: GxP, FDA 21 CFR Part 11, HIPAA, GDPR
We also integrate with your existing ecosystem — from Veeva and Medidata to custom LIMS and EDC platforms.
Our Engagement Approach
- Use Case Discovery & Feasibility Assessment
- AI/ML Model Design, Training & Validation
- Regulatory Risk Evaluation & Compliance Alignment
- Deployment, Testing, and Performance Monitoring
- Post-Go-Live Support & Iterative Optimization
Why Agile Genix for AI in Life Sciences?
Regulatory-Aware AI Engineering
We don’t just build models — we ensure they meet validation, auditability, and traceability standards set by global regulators.
Domain-Driven Model Design
Every workflow is designed in collaboration with clinical, regulatory, and scientific SMEs.
Scalability & Security at Core
Our AI solutions are built for real-world implementation at scale — with robust data pipelines, security architecture, and governance layers.
Results We've Delivered
- 40% faster regulatory dossier generation through NLP automation
- 2x improvement in signal detection accuracy for global pharmacovigilance
- 3-month acceleration in target validation using ML-based R&D modules
- $500K+ operational cost savings via automated case processing
Let’s Build AI That Drives Scientific Outcomes
AI isn’t the future — it’s the competitive edge today. Let Agile Genix help you design intelligent systems that elevate compliance, insight, and operational efficiency.