INTEGRATED PRODUCT DEVELOPMENT - QUICK REFERENCE GUIDE

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A guide to FDA meetings

Meetings with the FDA are extremely beneficial to build a relationship that will last many years Meetings with the US Food and Drug Administration (FDA) help you create a viable regulatory strategy and also ensure your drug is on the best path to receiving market approval. Typically, FDA meetings will only last one hour, and you will only have one chance to get it right, so it’s vital they run smoothly so that you meet your objectives.
PharmaLex US expert Mark Lane 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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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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Technical Helpdesk

The Technical Helpdesk is a service solution that provides your team with quick and easy access to the breadth and depth of expertise of our Consultant team giving you the confidence that an SME is available to respond to your GxP queries as they arise, without having to go through the proposal/procurement process for individual/smaller queries

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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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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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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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