TIME TO APPROVAL IS THE KEY TO SUCCESS
Most companies focus on making it through the key milestones of drug development as fast as possible.
While this is indeed the way to "speed" up the process, it does not always lead in the end to an approval or the ideal label.
Our philosophy is that it is important to prepare a regulatory plan and engage global regulators early and often, since they are the ones that ultimately will agree to license your product for use in their countries. Without a mutual understanding of the scientific principles which will meet the burden of proof an approval will not be forthcoming, even if you manage to check off the milestones.
......navigating the drug approval process to success!.
Kaia Agarwal, M.Sc., President, Regulatory Compass LLC
Boston, MA USA
+1 617 784 7850