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.

Stubbs & Hensel Intervention

• Report Review: S & H reviewed all validation, cross-validation, sample analysis reports and all addendums and amendments for all species included in the NDA submission.
• Risk Assessment: S & H created a comprehensive list of all the regulatory risks ranked as low, medium and high risk.  All high risk issues as well as select medium risk issues were further investigated with each individual CRO and a means to mitigate each risk were derived and presented to our client.
• Mitigation: S & H worked with individual CROs to mitigate the regulatory risks associated with this NDA.

Result

The NDA submission was subsequently approved!