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Process Understanding for Submissions

Predictive, validated process models from DynoChem are increasingly used to demonstrate process understanding within QbD-based NDA submissions. These assure the regulatory authorities that your Science of Scale will successfully manage risks and ensure a high level of process control.

What our users say:
"DynoChem will play an important role in assuring the regulatory authorities that [running at] 10% of scale is not essential if the 'Science of Scale' is well understood."

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Relevant Customer Publications

"Application of DynoChem in CMC Regulatory Support", Reaction Science (2013)

"Lean and Green, the Value of API Process Design", Pfizer (2009)

"Roles of Mechanistic and Empirical Modeling / DoE in Achieving Quality by Design", GSK (2009)

"Application of Mechanistic Thinking to Create Process Understanding and Support QbD in Pharmaceutical Process Development and Scale-up", Scale-up Systems with contributions from GSK (2008)