Laura comes to the lean RAQA team with a Master’s in Biomedical Engineering and more than six years of regulatory experience in the medical device and pharmaceutical industries.

She has done extensive work bringing non-prescription drug products to market through the FDA’s over-the-counter (OTC) drug review process. Non-prescription drugs approved by the FDA are granted an OTC monograph, which serves as the “rule book” for the drug’s release.

Laura also has expertise in FDA submissions of generic drug products, or abbreviated new drug applications (ANDAs). These submissions require no pre-clinical or clinical data to demonstrate safety and effectiveness, but must still show that the product performs the same way as the innovator drug.

Fun Fact: Laura has led a somewhat nomadic life and has lived in seven states and 2 countries.