Dalal O. Murgai
Chief Operations Officer
Dalal Murgai is the Chief Operating Officer and co-founder of GXP Quality Systems, LLC with key responsibilities for the overall management of the company as well as specific responsibility for the Research, Development, Clinical and Regulatory filing aspects of the consultancy. She also founded and was President of Regulatory Outsource Consulting, Inc. (ROC), a regulatory and quality assurance consulting firm that advised biopharmaceutical and medical device companies in phase 1-3 clinical development and provided services in the preparation and submission of regulatory and clinical documents.
Dalal has over 30 years in the biopharmaceutical/medical research industry, with emphasis in early phase development of drugs and biologics. She has held positions in both Regulatory Affairs and Quality Assurance, where she prepared technical documents for submission to regulatory authorities and was responsible for quality oversight of preclinical, clinical, and drug manufacturing, testing and control operations. Areas of expertise include GLP, GCP, and GMP, (GXP) compliance and training, technical writing, advising on operational issues, managing interactions with regulatory agencies, as well as preparation and evaluation of standard operating procedures, technical documents (including clinical, preclinical, and CMC records, protocols and reports), and regulatory submissions (IND, NDA/BLA, CTA, MAA, and module 2 updates) for both U.S. and international regulatory authorities.
Dalal began her career at MD Anderson Cancer Center in behavioral and cancer research. Prior to consulting, Dalal held positions in preclinical biology, QC/QA, and Regulatory Affairs from bench level to management for GeneMedicine, Inc., Aronex Pharmaceuticals, and Agennix Inc. As a consultant, her clients ranged from virtual start-up to large medical device and pharmaceutical companies, academic hospitals/institutions, and CROs, and individual entrepreneurs. She obtained a bachelor’s degree from Texas A&M University in Wildlife and Fisheries Sciences in 1988, holds memberships in DIA, RAPS, and SQA, and currently serves on the DIA GCP Special Interest Action Committee (SIAC), and the Texas A&M University Biotech Career Panel. She previously served on the Houston BMTC Steering Committee (2004-2007), the BioHouston Regulatory Affairs Roundtable Steering Committee (2004-2007), the Industry Advisory Counsel for the Texas A&M University PPIB (2003 -2015), and served on the Western Regional Center of Excellence (WRCE) in Biodefense, Product Working Group with UTMB (2012-2015).