The US Food and Drug Administration requires standard for exchange of non-clinical data (SEND) datasets for most non-clinical studies in regulatory submissions. As of 2025, the European Medicines Agency is also piloting SEND as part of its proof-of-concept program. Globally, the regulatory authorities are shifting towards the standardization of non-clinical data to streamline the processes and improve efficiency and transparency.
At Alira Health, we deliver fully validated, submission-ready SEND datasets that help you meet regulatory expectations efficiently and confidently. We transform complex non-clinical study data into fully compliant, submission-ready SEND datasets, accelerating your path to approval and ensuring your data speaks the regulator’s language.
