Sustainable Compliance - The Challenges of Achieving and Maintaining CMC Compliance

This paper highlights just a few key points that need consideration ahead of achieving and maintaining CMC Compliance in a more sustainable way.

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Analysis of EMA's Product Management Services, the current Implementation Guide and future Development

This paper gives details on the background and recommended steps about the Analysis of EMA’s Product Management Services, the current Implementation Guide and future Development.

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Software, AI and Medical Devices - What's Up?

This paper highlights just a few key points that need consideration ahead of the new Medical Device Regulation 2017/745 (MDR) being implemented in 26th May 2020.

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Pre-IND meetings - don't overlook this key opportunity for early FDA feedback

This first meeting establishes the tone of your Agency relationship, and as one of the desired outcomes, you want the Agency to gain respect for your company and your science.

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Differing CMC requirements: US and EU

Different CMC regulatory requirements in various regions impose obstacles when considering expansion into other markets.

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Five secrets of great publishers

The FDA’s mandate for life science companies and manufacturers to submit information in electronic
format has solidified the Regulatory Publisher’s function as being essential to the drug development
process.

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