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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:
  • Broad range of products 

    • Prescription, Rx to OTC Switch, Non-prescription New Drug Submissions, Monographs, Natural Health Products, Medical Devices, Cosmetics, Consumer Products and Pesticides 

  • All aspects of submissions 

    • Non-clinical, Clinical, Chemistry and Manufacturing Controls, Environmental Assessments

  • Providing business orientated solutions for product launch, maintenance, and promotion such as

    • negotiating advertising approvals

    • strategies to address supply issues

  • Participation in external and internal audits

  • Head of the Consumer Healthcare Regulatory Affairs departments at Pfizer & Bayer 

  • Member on the Consumer Healthcare Leadership teams at Pfizer & Bayer 

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