I have been working for the pharmaceutical industry for over twenty years. I began my career as a chemist in the quality control laboratory, moved to research and development and settled in regulatory affairs-- chemistry, manufacturing and controls. I have extensive experience in preparing Module 3 of global filings for new medicinal products during clinical trials and also for commercial applications. This module includes the detailed description of both the active drug substance and drug product characteristics, manufacturing, and testing requirements. I have worked on global filings including for the US FDA, the European EMA, Health Canada and the Japanese PMDA. These health authorities have harmonized requirements for the registration of new pharmaceuticals. I have experience in several dosage forms, including tablets, capsules, and injectable sterile solutions.