ResourceLab Informatics
Standard for Exchange of Nonclinical Data
7 Sept 2026SEND (Standard for Exchange of Nonclinical Data) data is now a submission requirement for all in-scope nonclinical study designs. Sponsors are ultimately responsible for the submission of the SEND dataset package to the FDA as a part of the eCTD submission. As SEND standards are always evolving, this SEND E-Guide from Charles River serves as a resource helping you to stay ahead of this changing landscape. Gain a better understanding of the factors that will determine the success of your nonclinical submission.
Resource details:
Resource type: Application note
Page count: 10
Read time: 12 mins
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RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices.