FDA Submission Process

FDA submission process is the submittal process a new drug must undergo by the Food and Drug Administration to be determined safe and effective.

Case Study

Expert Pharmacologist for Patent Process Consultation

A pharmacologist expert was sought for pre-litigation consultation involving a time-release formulation for opioid drugs.

Case Study

FDA Submission Expert in Clinical Trials

A FDA submission process expert was requested to evaluate the clinical trial of a transdermal application of an anti-inflammatory drug.