Regulatory Solutions for Rx, Switch, OTCs, NHPs, Medical Devices and Cosmetics
Regulatory Unboxed excels in:
Providing speed to market solutions and communicates risks/opportunities to launch compliant products
Identifying strongest advertising positions and developing labels with unique positions
Producing clear, organized submissions catered for Health Canada’s requirements
More About Michele Kay
Experience Includes:
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Broad range of products
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Prescription, Rx to OTC Switch, Non-prescription New Drug Submissions, Monographs, Natural Health Products, Medical Devices, Cosmetics, Consumer Products and Pesticides
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All aspects of submissions
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Non-clinical, Clinical, Chemistry and Manufacturing Controls, Environmental Assessments
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Providing business orientated solutions for product launch, maintenance, and promotion such as
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negotiating advertising approvals
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strategies to address supply issues
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Participation in external and internal audits
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Head of the Consumer Healthcare Regulatory Affairs departments at Pfizer & Bayer
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Member on the Consumer Healthcare Leadership teams at Pfizer & Bayer