Our services



· 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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PO Box 128, Mountain Lakes, New Jersey, 07046, USA

(973) 334-4710

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