• Product Stewardship: Health risk assessment, management and communication: Spherix staff has assisted clients in all aspects of product stewardship. An understanding of the potential risks to human health posed by exposures to contaminants in foods and consumer products is a central component of the stewardship process. This includes: risk assessment to evaluate the risks to human health and safety and to the environment associated with product manufacture, storage and transport, use, and disposal; risk management to eliminate, or limit to acceptable levels, the risks identified in the risk assessment activity and; risk communication to inform the public, government officials, employees and customers about product risks and how they are being managed.
   
• Study oversight and management: Spherix designs, places, and monitors clinical trials and other safety and efficacy studies, including the development of protocols, dosage and exposure assessments, oversight of patient recruitment and site management entities, and the preparation and submittal of required documentation.
   
• Regulatory compliance: Spherix represents clients before regulatory authorities such as the FDA, EU, EPA, and CSPC; conducts assessments under California Proposition 65; and resolves FDA & FTC regulatory issues regarding the U.S. Dietary Supplement Health and Education Act (DSHEA) of 1996. We help our clients pursue GRAS (“generally recognized as safe”) determinations; and prepare and submit notifications under the FDA’s food contact notification (FCN) program. We assist in the establishment of regulatory strategies for our clients, including utilizing the traditional petition process or new regulatory strategies. We address recent regulatory developments; develop data waiver strategies, and perform Good Laboratory Practice (GLP) inspections.
   
• Safety and efficacy review and evaluation: Spherix provides product claim substantiation; We review and evaluate safety data relating to toxicity; develop efficacy-testing protocols, and develop safety and efficacy data for marketing approval.
   
• Marketing strategy and analyses: Spherix helps its clients establish marketing strategies by providing guidance in discovery, dose selection for safety assessment, chemistry and manufacturing, efficacy assessment, and post marketing surveillance. We 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.

For more information, please contact us at info@spherix.com.