Regulatory Submission-Ready Solutions
We specialize in submission-ready deliverables aligned with global regulatory requirements (FDA, EMA, PMDA).
Before First Subject In
SDTMs finalized and submission-ready ahead of FSFV.
Within 4 Weeks
From Final Protocol Approval to live eCRF — faster study startup.
Within 12 Weeks
Last Subject Last Visit to Database Lock — rapid and reliable closure.
Our expertise covers:
eCTD-Compliant Submission Packages
Fully formatted eCTD-ready datasets and documents for streamlined regulatory filings.
CDISC-Compliant Dataset Conversions
Legacy data conversion to CDISC standards (SDTM/ADaM) to meet regulatory compliance.
Regulatory Responses and Audit Support
Expert support for regulatory queries and audit preparation to ensure smooth approval processes.
Accelerate Your Trails With Us
With our innovative solutions, we empower healthcare providers to make smarter decisions and achieve long-term success.