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A License Application requires a detailed CMC package of information to support submission. The Drug Substance and Drug Product packages are tailored according to:
A step-wise approach is applied to ensure collaboration and Customer alignment throughout the CMC journey.
The CMC data package encompasses analytical development and method validation, small scale process characterization studies, GMP validation batches (PPQ batches), process validation studies and product-related analytical studies.
A combination of small scale and large scale experimentation is used to establish scientific evidence that a process is capable of consistently delivering quality products.
Our regulatory experts can support you through the journey with:
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