Seasoned professional providing guidance and expertise in the - TopicsExpress

Seasoned professional providing guidance and expertise in the areas of regulatory affairs and quality assurance for the biopharmaceutical industry. More than 30 years’ experience in all areas of drug/biologic/device development. Areas of expertise include Pharmaceutical/Device Development Plans, Regulatory Strategy, Regulatory CMC, Quality Systems, Compliance, and Clinical Development strategies for companies with pharmaceutical, device, and biopharmaceutical medical products being developed or distributed in markets regulated by the US FDA, Canada, the European Commission, and other international regulatory agencies. Successful track record with more than 20 approved NDAs/BLAs.

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