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With over 34 years of regulatory compliance experience in the life sciences industry working with clients in the medical device, pharmaceutical, biologic, and food sectors, Mutahar Shamsi, a non-lawyer, facilitates clients in striving for "Quality beyond Compliance" by developing and executing regulatory and risk strategies across people, process, and technology. Using extensive experience in formulating and executing U.S. Food and Drug Administration (FDA) regulatory approaches, he provides a unique perspective and insight to assist clients globally in navigating perceived regulatory barriers into positive remediation steps. Mr. Shamsi has helped clients mitigate data integrity concerns, close compliance gaps in preparation for pre-approval inspections, align combination product development and quality system processes, prepare for testimony concerning GLP and GCP regulations, assess quality audit practices, and advise in managing and remediating a Consent Decree.

Previous Experience

  • Deloitte & Touche, Specialist Leader, Life Sciences and Healthcare
  • U.S. Food and Drug Administration, District Director