Case Studies

At Stubbs & Hensel one of our missions is to minimize the regulatory risk for the bioanalytical component of our client’s drug submissions. Here are some case studies which demonstrate how we work with clients to accomplish this.

FDA Warning Letter

Issue: A major contract research organization (CRO) received an FDA warning letter requiring them to either reassay all samples or re-run the clinical and bioanalytical portions of all bioequivalence studies for the past 5 years for due to misconduct and poor scientific practices.

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. 

GLP GAP Analysis

Issue: S & H was contacted by a CRO to perform an assessment of their capability to offer GLP bioanalytical services.

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.