Focus On SEND: Standard for Exchange of Nonclinical Data
Capabilities
The US FDA has requested that by the end of 2017, Investigational New Drug (IND) submissions will be conducted in a SEND-compliant format as part of its efforts to improve the efficiency and quality of the review process and the rigor of scientific assessment. Data submission to support New Drug Application (NDA) and Biologic License Application (BLA) filings with the FDA has already been mandatory.
Recently, Pharmaron has been implementing hardware and software necessary to meet the SEND guidelines. We are in the process of fully validating the SEND system by the middle of 2017, thereby meeting the timeline set by the FDA for regulatory filings. Pharmaron is committed to ensuring full compliance with regulatory requirements and the high quality of studies conducted at our facilities.
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