Spherix Consulting helps clients make science-based decisions. With its global team of experienced advisors, Spherix evaluates health and environmental risks of legacy products, their components and potential contaminants that are under regulatory scrutiny, subject to product liability and tort litigation and/or exposed to changing scientific standards or public perceptions. Spherix also evaluates risks associated with new products and helps clients devise and implement strategies to mitigate and manage these risks.
Above all else, Spherix ensures clients craft demonstrable processes that place ongoing responsibility on the company to identify, monitor and manage the health, safety and environmental issues concerning its products and packaging.
Product Stewardship
Spherix consultants pride themselves on their ability to assist clients in the design of product stewardship programs that incorporate risk management options and risk communication strategies. 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.
Product Safety & Efficacy Review
Spherix provides product claim substantiation services to its clients. Consultants review and evaluate safety data relating to toxicity; develop efficacy-testing protocols, and develop safety and efficacy data for marketing approval.
Product Regulatory Compliance
Spherix represents clients before regulatory authorities including the FDA, EU regulatory authorities, the 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. The company help clients pursue GRAS (“generally recognized as safe”) determinations; and prepare and submit notifications under the FDA’s food contact notification (FCN) program. Spherix assists in the establishment of regulatory strategies for clients, including utilizing the traditional petition process or new regulatory strategies. In addition, company consultants help address recent regulatory developments; develop data waiver strategies, and perform Good Laboratory Practice (GLP) inspections.
Market Strategy Analyses
Spherix helps its clients establish market 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.
Study Oversight & Management (CRO Capabilities)
Spherix helps its clients design, place and monitor pre-clinical and 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. Spherix offers its clients personal service and attention for study oversight and management, leveraging its consultants’ years of experience and proven success.