An RSI Understanding Risk method
Regulatory readiness assessment
Regulatory readiness assessment is one of the methods used by Risk Sciences International to better understand risk.
Broadly
Regulatory readiness assessment evaluates whether a technology, product, or process is prepared for regulatory review or compliance. It examines documentation, data sufficiency, alignment with standards, and organizational capacity. This method helps anticipate barriers and identify areas needing further evidence or revision.
More specifically
RSI provides regulatory readiness assessments for clients in chemical safety, biotechnology, and public health innovation. The firm benchmarks against relevant jurisdictional expectations and highlights critical gaps. RSI ensures that risk documentation is clear, complete, and formatted to facilitate regulatory engagement, reducing time to approval or endorsement.