Reclamation Projects Represent Challenging Times

Reclamation projects have financial consequences. Once the Client understands their project is non-compliant with FDA, 21 CFR 312, ICH, GCP Guidelines and/or the protocol, SOPs, and corporate policies and procedures; hundreds of thousands, if not millions, of dollars have already been spent. Reclamation projects often cause the Client to in effect, re-pay for completed data in order to bring the project into compliance. Corporate timelines also require adjustment.

Additionally, reclamation projects often occur in a tense environment. Once reclamation is required, both the Client and Investigator staff have already invested many hours of work into the project that must be readdressed and corrected.  In most cases, Client and investigator staff are required to double their time and investment for project completion. They typically are not pleased.

RESQ understands the issues and the consequences. We have been there to help many times and are here to help you during this difficult period.