Modality Solutions integrates cold chain management systems. You get results because we focus on implementation, not just defining regulatory requirements. A properly integrated cold chain ensures regulatory compliance, product quality, and patient safety by providing a multi-layered approach that combines best practices of process validation, systems qualification, and risk assessment with the most applicable technology. We offer best-of-breed technology solutions integrated together into your quality management systems. We deliver proper documentation for qualification, validation, along with training aligned with the necessary procedural controls, visual controls, and monitoring.

Services:
• cGMP Readiness Assessments
• Product Characterization and Stability Studies for Distribution
• Controlled-environment Logistics Regulatory Submissions
• Cold Chain Network Design and Transport Lane Validation
• Thermal Packaging Design and Qualification
• Clinical Trial Operations Cold Chain Management

Our Advantage Transport Simulation Laboratory™ provides valuable data on the impact of five environmental hazards – temperature, shock, vibration, pressure, and humidity on biologic drug formulations, pharmaceuticals, medical device combination products and more.