Regulatory

Dr. Nason has managed regulatory programs and submissions of all product types to Health Canada as well as medical devices and radiopharmaceutical submissions to the USFDA. Services range from the “big picture” such as development of regulatory strategy to the “details” like completion of ready-to-send regulatory submissions.

Proven capability in the preparation of all submission types:

• Regulatory meetings
• Clinical Trial Applications
• New Drug Submissions
• Post-marketing changes
• Electronic submissions (involves third party service provider)

Experience handling the following product classes:

• Pharmaceuticals
• Biologics
• Radiopharmaceuticals
• Medical devices

Provision of additional related services:

• Pharmacovigilance
• Marketing Material Review
• Chief Medical/Scientific Officer in Canada