· Thought leadership working with Regulatory Authorities and Sponsors to develop the most appropriate pathways for Rx to OTC Switch
· Assessment and analysis of both the the Regulatory and Commercial Opportunity
· Design and preparation of the Drug Facts Label
· Hands on development of the molecule through the appropriate Switch pathway in consultation with the FDA
· Preparation for the initial Pre-IND meeting
· Design and implementation of the required studies including label comprehension, self-selection and actual-use
· Preparation for Advisory Committee Review
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