PharmaStat works on enough submissions that we always have a few in review at the FDA at any given time. We work closely with the FDA review divisions to solve their issues so that our clients avoid the fire hose of requests that can set back their PDUFA date by months. Most importantly, we help our clients strategize the content of their submission to deliver exactly what the review division needs, no more and no less. This planning yields two benefits: it eliminates noise and distractions in the submission, and it saves our clients money by eliminating work that they may have thought necessary.
Once the submission strategy is in place, PharmaStat has the processes, tools and templates to produce, audit and validate the entire range of Biometrics documentation for an eCTD submission.