Steps to building regulatory readiness for the next wave of clinical submissions

The regulatory submission process in life sciences is becoming less about assembling documents and more about proving trust. For years, submission readiness was largely treated as an end-stage operational milestone: finalize the analysis, validate the outputs and package everything for regulators. But that model is beginning to break down under [...]

Steps to building regulatory readiness for the next wave of clinical submissions was published on SAS Voices by Matt Becker