Dipali MacAllister, PharmD, RPh, RAC-US
Senior Principal Consultant
Dipali specializes in scientific, regulatory, and project management consulting services to manufacturers of U.S. Food and Drug Administration (FDA)-regulated products in the U.S. and in Europe. A registered pharmacist with experience in industry and various practice settings, Dipali’s expertise includes support for regulatory affairs and clinical development for pre-Investigational New Drug Applications (pre-INDs), INDs, and New Drug Applications (NDAs), including authoring clinical and regulatory sections and documents; preparation of regulatory submissions; project management; adverse event and drug safety reporting; due diligence product assessments; and postmarketing activities. Dipali has a Pharm.D. from the Bernard J. Dunn School of Pharmacy, Shenandoah University, a B.S. in Pharmacy from the University of South Carolina College of Pharmacy, and an A.B. in Chemistry from Duke University.