Project Description

We worked with a medium sized pharmaceutical company in California to bring a life changing drug product to the US marketplace via the FDA’s NDA process. Our support included drug substance review, drug product review, batch record review, regulatory compliance strategy, vendor controls, stability data review, and clinical data review. We worked closely with our client to implement a robust quality system and stayed with them through the FDA inspection and eventual approval. This drug has gone on to become a 3 billion dollar product.