...however, while there is usually a need to "speed" up the process, this does not always lead to an approval or the best label.
Prepare a Global Strategic Regulatory Plan
Engage Regulators Early and Often
Without a mutual understanding of the scientific principles that will meet the burden of proof, an approval will not be forthcoming, even if you manager to check off the milestones.
...Expertise with the Regulators is the Key to Success!