Drug Development

Drug Development Project

Issue and Impact: S & H has worked with a small pharmaceutical company client that had no internal bioanalytical or drug development expertise for the handling of their drug development project. 

We are filing our NDA in 6 months. Is our filing at risk and if so what can we do to minimize the risk?

Issue: Our mid-sized pharma client had GLP and Clinical data from ELISA and LC-MS/MS for the same drug candidate.  In addition, the data generated were from multiple CROs over approximately 6 years of conducting studies.