
Andrew MacKessack-Leitch
Co-founder, Science & Quality
Andrew has spent 11+ years in CMC, authoring dossiers, designing method validations and defending them, and the submissions they are part of, in front of regulators across Europe, the US and Asia. He has been the technical lead on data integrity and validations under regulatory inspection, and has seen first-hand what can happen when a change isn't carried through every document it touches.
