At PRETOX CONSULTANCY (PTC), we specialize in SEND (Standard for Exchange of Nonclinical Data) preparation to ensure your study data meets FDA and global regulatory submission requirements. Our experts convert complex nonclinical datasets into SEND-compliant formats, maintaining data integrity, traceability, and accuracy throughout the process.
We provide end-to-end support — from raw data evaluation to final SEND package generation and validation — ensuring seamless submission and review by regulatory agencies.
- One of the required standards for data submission to FDA.
- It is an implementation of the SDTM standard for nonclinical studies.
- specifies a way to collect and present nonclinical data in a consistent format.
By combining technical precision with regulatory insight, PTC ensures your nonclinical data is SEND-ready, submission-compliant, and review-friendly — minimizing delays and maximizing regulatory confidence.

