Spherix staff provides both regulatory and scientific support for all aspects of the U.S. Food and Drug Administration’s (FDA) approval process for pharmaceuticals, biologics and medical devices. This support includes preparing and reviewing protocols for animal (pre-clinical) testing and summarizing results; preparing and reviewing protocols for clinical (human) trials; assessing the health risks to humans from contaminants or excipients; preparing INDs and NDAs; serving as the client's technical contact with FDA scientists; and participating as the client’s representative in meetings with the FDA.
Spherix also helps its life science clients establish marketing strategies by providing guidance in discovery, dose selection for safety assessment, chemistry and manufacturing, efficacy assessment, and post marketing surveillance.
Consultants provide full support from discovery through post-marketing surveillance with the aim of ensuring that safe and effective new products reach the public in a timely fashion.
Spherix Consultants with expertise in Pharmaceuticals include Claire Kruger, Wally Hayes, Ron Slesinski, Susan Phillips, Rob Lodder, Longming Lu
