Regulatory Outsource Consulting, Inc.
Phone: (281) 367-3949
info@Regoutsource.com
Welcome to Regulatory Outsource Consulting, Inc.

Specializing in

  • Early phase development activities
  • GCP audits
  • GXP training
  • Regulatory submissions

Our Team

Dalal O. Murgai, President and Principal Consultant

Ms. Murgai has more than seventeen years experience in the cancer research and drug development industry, with emphasis in early phase development of biological and pharmaceutical drugs. She is primarily involved with regulatory submissions and quality oversight of biologics and drug development. Prior to founding Regulatory Outsource Consulting, Inc., Ms. Murgai worked in the biotechnology industry with experience ranging from preclinical development of drug candidates to QA oversight of manufacturing of active pharmaceutical ingredients and final drug products, to regulatory oversight of clinical trials and submission of marketing applications. Her expertise includes quality assurance auditing for GCP, GMP and GLP compliance, and the preparation of documentation, including a variety of reports and regulatory submissions for products at all stages of development, for both U.S. and international regulatory authorities.

Affiliates

ROC works with a network of consultants and other senior industry experts to provide additional expertise or manpower as needed for related areas including manufacturing, quality control/analytical testing, preclinical pharm/tox study design/consulting, clinical monitoring and project management. Our affiliates are highly regarded professionals who seamlessly compliment the services that we offer our clients.