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Designing Regulatory strategy
Designing Regulatory strategy
Client:
Large Pharmaceutical company.
Client Challenge:
Our client required our expertise to guide their regulatory strategy for their oral, extended-release (ultra-long) capsule.
G&L was also engaged to provide strategic regulatory guidance on how to classify, position, and register the product with FDA, to maximize the client’s asset.
G&L Solution:
With expert guidance from one of our Senior Regulatory Strategists, we helped guide the client’s team on how to present the novel therapy to FDA and showcase the required supporting data.
We also conducted a review and authoring of CMC, non-clinical, and Clinical components of an IND and Type II and V DMFs associated with the program and provided full eCTD publishing and FDA Gateway submission services.
Outcome:
With our support, our client was able to file their IND and DMF on time, for the drug-device combination product.
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