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Systems Engineering for Complex Portable Medical Device Development

As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount. Taking a systems-engineering (SE) approach to development provides a holistic, organized, and deliberate method for identifying as well as reducing both patient and business risks early in the process. Furthermore, it facilitates efficient progression throughout the entire product development life cycle.
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News and Press Releases

Gerresheimer opens a new plant for the production of pharmaceutical primary plastic packaging in China

Düsseldorf/Changzhou, December 11, 2019 – A new plant for producing plastic pharmaceutical packaging has been set up in the Chinese city of Changzhou to help satisfy the high demand for Gerresheimer’s primary packaging in China in the future. Today the new facility will be officially opened.
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White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events

Event profile: PHARMAPACK 2020

6-7 February 2020,

Nemera will join more than 5,000 senior pharma professionals at Pharmapack, which will take place in Paris, on 5-6 February 2020. Meet Nemera at the booth C56 to discover its innovative drug delivery devices and its end-to-end development offerings! 
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