Wow, common scenario for organizations watching their resources and tight on time. Short cuts can quickly draw fire from regulatory authorities, so starting a focus there may be the best strategy. Communicate with them (through your internal Regulatory) to demonstrate the significance of your product to the healthcare community and lay out a plan to prove stability along the way with solid justifications. You may need to be quite creative, but these days, “quite creative” solutions seem to be gaining a foothold. You might even explore some accelerated avenues such as an Isoconversion program.
