Cold Chain Management Systems
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Modality Solutions specialises in the implementation of cold chain management systems for the pharmaceutical industry.
Thermal packaging for pharmaceuticals
Modality Solutions offers cold chain thermal packaging qualification and transport validation, as well as logistics in regulated and controlled pharmaceuticals, biologics, and combination medical device industries.
The company integrates your quality management systems, risk management, product stability requirements and validation activities. Data gained from this can be provided on the impact of environmental hazards to quality attributes of any product.
Modality Solutions offers product characterisation, process validation, monitoring, and controls, as well as clinical trial operations.
Safeguarding services for supply chains
Modality Solutions has more than 100 years of cold chain experience. The company's team develops the necessary standards, policies, procedures, and processes to safeguard the security of a product's supply chain.
Innovators, research-based developers, and scientists consider safeguarding their cold chain as an important step in reducing regulatory risk, while decreasing the product approval time.
Modality Solutions guarantees:
- Appropriate expertise and techniques to assess, control, and communicate risk as part of an ongoing management review process
- A lifecycle approach to process validation including design, qualification, and verification
- Better integration of product formulation, controlled environment logistics, and packaging design
- Innovative quality control, corrective and preventive actions (CAPA) strategies, and root cause analysis
- The application of technology to achieve gains in compliance, quality, and safety
Transport simulation laboratory for studying environmental hazards
With Modality Solutions' unique transport simulation laboratory, users can concurrently study the impact of temperature, shock, vibration, pressure and humidity, five main environmental hazards of drug formulation.
The laboratory is an independent, third-party transport simulation facility, which meets good manufacturing practice (GMP) standards for all types of packaging and formulations.
Users can compare results against expiry date stability studies to verify the candidate product formulations able to withstand the demands of the international supply chain.
Modality Solutions offers thermal packaging design and qualification processes to lessen or eliminate transportation environmental hazards in the supply chain.
The company ensures regulatory compliance, product quality, and safety during clinical trials and into commercial distribution. All solutions are integrated, holistic, and practical, compared with traditional packaging companies.
Cold chain logistics and transportation validation
The company helps clients with regulations and compliance for cold chain management and has substantial experience in design, validation, implementation, and monitoring in this area.
Modality Solutions designs and validates cold chain controlled-environment logistics solutions. The company provides validation master plans, documented protocols and reports, and a summary for Niologic License Application (BLA) or marketing authorisations worldwide.
Pharmaceutical clinical trial operations
Clinical trial management provides various advantages such as medical and clinical monitoring, product safety, and project handling.
Ongoing monitoring, staff training, and data query resolution is available, as well as drug supply accountability and regulatory document preparation, review, and collection.
About Modality Solutions
A privately owned company, Modality Solutions provides engineered solutions for highly regulated industries.
Modality Solutions has contributed to Life Science Leader, PharmaVOICE, Cold Chain IQ, Pharmaceutical & Medical Packaging, Pharmaceutical Outsourcing, World Trade WT100, Supply Chain Brain, Healthcare Packaging, Pharmaceutical Commerce, and Specialty PHARMA Journal.
1238 Mossy Oak Drive
League City, Texas 77575
United States of America
+1 214 919 4629
+1 214 960 1519
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Available White Papers
Integrating Cold Chain Management Systems Competing priorities, changing expectations, cost pressures, sustainability initiatives, and emerging markets are some of the challenges facing cold chain management professionals every day.