This tool is designed to assist you in determining the readiness level of your technology
through an estimated calculation based on the criteria you have selected. This tool does
not guarantee your readiness level. All reports from this tool are to be considered
estimates and are subject to change. You can find additional information regarding
BRL on the NIIMBL website.
Technical Readiness
Has the technology performance been demonstrated at scale?
Has the technology been demonstrated in a relevant production
environment (with a drug candidate or a relevant model)?
Quality Readiness
Have the key performance parameters (KPP) been identified, and has the validation master plan (VMP) been developed?
Has the VMP and quality by design studies for the intended technology been executed?
Operational Readiness
Has the stakeholder management plan been developed?
(Identify stakeholders, development of implementation
strategy, risk mitigation, etc.)
Is there a production system in place for technology implementation?
Exit Strategy
Has the demonstrated technology met acceptance criteria,
and can it be reliably produced commercially?
Has the technology been demonstrated to manufacture pivotal batches
(e.g., phase 2B/phase 3/bridging studies, etc.) for approved IND?
