From Discovery to
Patient Delivery
Purpose-built for the unique challenges of life sciences. Oonru delivers end-to-end visibility, regulatory compliance, and operational excellence across biotech, medical devices, and diagnostics.
100%
Regulatory Ready
85%
Faster Batch Release
99.9%
Traceability
50%
Documentation Reduction
Life Sciences Challenges We Solve
Biotech, medical device, and diagnostics companies face unique operational and regulatory challenges that demand specialized solutions.
Complex Regulatory Landscape
Navigate FDA, EMA, ISO 13485, and global regulatory requirements across multiple product types.
R&D to Manufacturing
Bridge the gap from research through clinical trials to commercial manufacturing seamlessly.
Biologics & Cold Chain
Manage temperature-sensitive biologics with continuous monitoring and deviation alerts.
Traceability Requirements
Ensure end-to-end traceability from raw materials to patient for recalls and investigations.
Built for Your Segment
Specialized capabilities for every corner of the life sciences industry.
Biotechnology
Cell & gene therapy, biologics, biosimilars manufacturing with specialized workflows
Medical Devices
ISO 13485 compliant manufacturing and quality for Class I-III devices
Diagnostics & IVD
In-vitro diagnostics manufacturing with lot traceability and performance validation
Contract Research (CRO)
GLP-compliant study management with sponsor visibility and data integrity
Capabilities That Drive Results
Validated workflows and intelligent automation designed specifically for life sciences operations.
Unified Platform for Life Sciences
One platform for biotech, med-tech, diagnostics, and research organizations with industry-specific workflows.
- Multi-entity management
- Shared quality systems
- Cross-functional visibility
- Integrated compliance
Electronic Batch Records (eBR)
Paperless manufacturing with enforced workflows, real-time data capture, and review by exception.
- Guided execution
- Real-time deviation alerts
- Electronic signatures
- Auto-documentation
Laboratory Information Management
Integrated LIMS capabilities for sample management, testing workflows, and results tracking.
- Sample chain of custody
- Instrument integration
- Stability studies
- COA generation
Clinical Supply Management
Manage investigational products from manufacturing through distribution to clinical sites.
- Randomization support
- Blinding controls
- Expiry management
- Site replenishment
Regulatory Compliance Built In
Oonru is designed to meet the most stringent life sciences regulatory requirements worldwide—from FDA to EMA to ISO standards.
FDA 21 CFR Part 11
Electronic records and signatures
ISO 13485
Medical device quality management
EU MDR / IVDR
Medical device regulations
ICH Q10
Pharmaceutical quality system
cGMP / GMP
Good manufacturing practice
GAMP 5
Software validation framework
Validation & Compliance Package
- Installation Qualification (IQ) protocols
- Operational Qualification (OQ) documents
- Performance Qualification (PQ) templates
- System Design Specification (SDS)
- User Requirement Specification (URS)
- GAMP 5 risk assessment
- Computer system validation (CSV)
- 21 CFR Part 11 compliance attestation
- ISO 13485 quality manual integration
- Audit trail configuration guide
"Based on environmental data trends, Batch BIO-2024-089 has 23% elevated risk. Recommend enhanced monitoring."
"Adjusting feed parameters by 8% at T+72h historically improves titer by 12-15% for this cell line."
"New EU MDR guidance published. 3 procedures require updates. Generating gap analysis..."
AI That Understands Life Sciences
Our AI copilots are trained on life sciences workflows, regulatory requirements, and industry best practices—not generic business rules.
- Predictive quality analytics for proactive deviation prevention
- Process optimization recommendations based on historical batch data
- Automated regulatory change impact assessments
- Intelligent document drafting for regulatory submissions
- Natural language queries across batch records and QMS
Who Uses Oonru for Life Sciences
Organizations across the entire life sciences value chain.
Cell & Gene Therapy
Autologous and allogeneic therapies, viral vectors, plasmids
Biologics Manufacturers
Monoclonal antibodies, proteins, vaccines production
Medical Device Companies
Class I-III devices, combination products, implants
Diagnostics & IVD
Molecular diagnostics, immunoassays, point-of-care
CDMOs & CMOs
Contract development and manufacturing services
Precision Medicine
Companion diagnostics, personalized therapies
Integrates With Your Ecosystem
Connect Oonru with your existing lab instruments, LIMS, ERP, and quality systems.
Ready to Transform Your Life Sciences Operations?
Join leading biotech and life sciences companies who trust Oonru to power their compliance, quality, and manufacturing excellence.