Discovery / Non-clinical

Early 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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Clinical Development

Biosimilar 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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Authorization / Approval

A Guide to FDA Meetings

Meetings with the FDA are extremely beneficial to build a relationship that will last many years. PharmaLex US Partner Andrew Verderame has laid out a clear step-by-step guide to meeting with the FDA to help you get the most out of your meetings.

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Post-approval / Maintenance

Virtual 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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