{ Regulatory Affairs }
DaVita Clinical Research (DCR) conducts all investigations to comply with the GCP regulatory requirements of the Food and Drug Administration (FDA), as well as the current International Conference on Harmonization (ICH) guidelines. Stringent quality control throughout the process ensures full compliance in protocol, data, documentation, and report audits. DCR standard operating procedures (SOPs), test methods, and training documentation are maintained under strict document control by our quality assurance group. Our team and processes guarantee regulatory submissions free of errors and omissions.
Throughout your study, all documents and data are archived to ensure complete and accurate documentation, as well as adherence to regulatory retention requirements. Our staff and facility are available for consulting audits if requested.
Regulatory services:
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Regulatory and strategic consultation for early stage drug development
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Consultation, representation, and coordination of pre-IND (PIND) meetings with FDA
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Regulatory preparation and consultation for IND submissions
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Consultation, representation, and coordination of 510K meetings with FDA
