Gap analysis of a US CMC data package for a European submission

Challenge

A small regulatory company had been commissioned to review the development data package available from a US biotech company for a liquid inhalation product, with a view to using the data package for a New Drug Application submission. The regulatory company approached us asking for a gap analysis of the data package in relation to a European product license submission.

Solution

Our CMC consultant reviewed the CMC data package and provided the analysis, enabling the client to gain a clear picture of any gaps and respond as necessary before making the submission.

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