Medical Device Regulations
The Medical Device Regulation (MDR – (EU) 2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) present a significant challenge for medical device manufacturers. Our highly professional and experienced medical device team is available to provide support as required. Our team members’ experience includes regulators, notified bodies, and industry and cover a wide range of products.
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DownloadEarly Phase Modeling
A model is a simplified image of reality that describes the relationship between factors (events and consequences) that are important to a decision. The aim of modelling is to make a particular part or feature of the world easier to: Understand, Define, Quantify, Visualize and Simulate
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DownloadVirtual Auditing for GxP Compliance
COVID-19 represents an unprecedented challenge for life science companies seeking to maintain the continuity of pharmaceutical operations and product supply. Even before COVID-19, PharmaLex had developed and implemented a step-wise and risk-based methodology to deliver virtual audits.
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DownloadBiosimilar Development
The path to biosimilar development can be a very complicated and lengthy journey. As a recognized leader for the provision of first-in-class strategic consultancy in Biosimilarity Assessment, PharmaLex has created a infographic to illustrate the process.
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