Alex Smith understands the pressure pharmaceutical and medical device companies around the world face when working with the U.S. Food and Drug Administration (FDA) to resolve compliance and CMC concerns.

From small start-up companies to large multi-national corporations identified as leaders within the pharmaceutical and medical device spaces, Alex frequently works with companies to avoid further enforcement from the FDA. From developing corrective action plans to responding to FDA Form 483 inspectional observations, Untitled Letters, and Warning Letters; assisting companies through FDA-requested certified audit programs; and preparing recall plans, Alex is able to help companies navigate through the myriad of FDA regulations, requirements, and expectations.

Alex maintains a Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS). RAC is the only credential for regulatory professionals in the healthcare product sector.

Alex has traveled the world in preparing, assisting, and defending companies before routine and directed FDA inspections. Alex has also prepared and assisted in the execution of global remediation plans to help ensure that all company sites act in accordance with company expectations and FDA requirements.

Previously, Alex held several roles in research development, manufacturing process engineering, software development, and GMP facility commissioning at several pharmaceutical and contract manufacturing firms.