Product Life Cycle Management
FDA 21 CFR Part 820, ISO 13485, audits, design/change control experts
Change control & regulatory compliance
Quality, performance, clinical reliability, materials/methods/suppliers' control
Product & process integrity
Trained scientific experts, validated stability chambers, shelf-life studies
Stability study management
Optimized parameters, workflows, equipment, reduced COGS, increased yield
Process improvement & efficiency
Traceable complaint handling, technical support, full product knowledge
Customer complaint & lifecycle support
Turning Your Challenges into Results
Overcoming the challenges of your product’s journey
Compliant change control
Optimized stability & processes
Customer-focused lifecycle support
Your benefits with Helio
End-to-End Product Lifecycle Excellence
Choose Helio for ...
Comprehensive End-to-End Product Lifecycle Management
Full change control lifecycle management (submission, approval, implementation, documentation)
Impact assessments, FMEA, and validation plans for materials, methods, suppliers
Design control experts ensuring modifications meet regulatory and clinical requirements
Audit-ready documentation and traceability for all changes
Change Control & Regulatory Compliance
Product/process integrity: Validation and monitoring of materials, formulations, and critical process steps
Stability study management: ISO 13485-compliant, validated chambers, controlled temperature/humidity, trained scientists performing shelf-life studies, real-time monitoring, and reporting
Process optimization: Parameter optimization for yield, cycle time, and cost of goods (COGS) reduction, workflow improvements and equipment calibration
Continuous risk assessment and documentation for regulatory compliance
Product Integrity, Stability & Process Improvement
Structured complaint handling: Standardized investigation process with root cause analysis (e.g., 5 Why)
Technical support: First-line and second-line support for client and end-user inquiries, including product-specific troubleshooting
Full lifecycle knowledge: Product experts, managed design, manufacturing, stability, and regulatory aspects to maintain quality and customer satisfaction
Documentation & traceability: All complaints, investigations, and resolutions recorded in QMS