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Innovative solutions to advance your pipeline on your timeline
Develop a scalable process and supply non-clinical studies culminating in IND submission
Ensure the route is suitable for commercialization and optimize the process while maintaining continuity of clinical supply
Finalize robustness testing and impurity control strategy; present a cohesive narrative that demonstrates process understanding and control of product quality
As regulatory agencies continue to embrace the tools of quality risk management, it is incumbent upon those of us in industry to make use of these tools to develop better processes more efficiently.
From vendor to sponsor, from candidate nomination to process validation and NDA/MAA submission
CMC development is a multidisciplinary effort, and doing great work is only possible with great communication. I prioritize conveying ideas clearly – to company leadership, to CMC colleagues, to vendors, and in regulatory submissions.
Development work should be guided by experimental results; process design is a question not of knowing but of proving.