Modality Solutions integrates cold chain management systems to ensure regulatory compliance, product quality, and patient safety. We combine best practices of process validation, systems qualification and risk assessment with the technology solutions for monitoring, controls, and packaging. Our clients receive proper documentation for qualification, validation, along with training aligned with the necessary procedural controls, visual controls, and monitoring. We have integrated LoJack SCI’s leading tracking and monitoring solutions into our cold chain management solutions for select high value cargo and highly-regulated supply chain markets.
Some of the services we provide include: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification. In addition our proprietary Advantage Transport Simulation Laboratory™ helps companies test the effects of transportation on their formulations from discovery through distribution. The simulation laboratory concurrently provides data on the impact of five environmental hazards – temperature, shock, vibration, pressure, and humidity on drug formulations, pharmaceuticals, and medical device combination products.
Founded in 2011 by four pharmaceutical industry experts, Modality Solutions is a privately-held company that sets itself apart by focusing on implementation, not just defining regulatory requirements. Our team delivers engineered solutions for highly regulated industries. We have helped more than 20 leading biotech and pharmaceutical companies integrate their cold chain management systems. As subject matter experts, we have contributed to features in the following industry print / digital publications: Pharmaceutical Online, Life Science Leader, PharmaVOICE, Cold Chain IQ, Pharmaceutical & Medical Packaging, Pharmaceutical Outsourcing, World Trade WT100, Supply Chain Brain, and Specialty PHARMA Journal to name a few.
Visit www.modality-solutions.com for more information.
League City, TX 77573
Contact: Gary Hutchinson