We like to keep our readers up to date on complex regulatory issues, the latest industry trends and updated guidelines to help you to solve a problem or make an informed decision.
Latest Blog posts
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Importance of Quality Management Review for Medical Devices
If you are an innovator developing a device, it is critical to understand the purpose and innerworkings of quality management…
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How can you take advantage of China’s accelerated regulatory pathways for your product development?
Global drug innovation in the East has significantly increased in recent years. China is one of the major players and…
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The EU Regulatory Framework for Microbiota Transplants: An Industry Perspective
The current European regulatory framework for Blood Tissue and Cells is being replaced by a new Regulation, which includes a…
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Key Points in the CTR Transition of Clinical Trials
Are you an innovator with a product undergoing clinical trial? This article covers all you need to know about the…
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Critical Materials considerations for Cell and Gene therapy product development – Part 2
In Part 1 of this blog, we covered the definitions of Starting Materials, Raw Materials, and Ancillary Materials. In Part…
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Critical Materials considerations for Cell and Gene therapy product development – Part 1
Raw and starting materials are an essential part of cell-based and gene therapy products (CGT). Frequently, the development of Cell…
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FDA Meeting Series: How, When and What – EOP Meetings
End-of-phase (EOP) meetings occur when development has reached the end of a particular phase and is ready to move to…
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FDA Meeting Series: How, When and What – Pre-IND Meetings
Pre-IND Meetings What: Pre-Investigational New Drug application (Pre-IND) meetings are formal PDUFA Type B meetings held between a sponsor…
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