ChromaDex - Spherix Consulting
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ChromaDex - Spherix Consulting, a division of ChromaDex, Inc.

Spherix Consulting, a division of ChromaDex, Inc.

Spherix Consulting is a global team of experienced advisors who provide their clients in the food, dietary supplement, consumer product, and pharmaceutical industries with scientific solutions that result in regulatory success. Spherix's experts evaluate and manage risks associated with new and legacy products under regulatory scrutiny, subject to product liability and tort litigation, and/or exposed to changing scientific standards or public perceptions. Spherix Consulting provides the expertise in scientific assessment, regulatory submission, and product stewardship to ensure successful navigation of an ever-changing world-wide regulatory climate.

Whether you are working with a dietary supplement, food ingredient, or finished product, Spherix Consulting can assist you in navigating the regulatory environment successfully and expediently by helping you select the best regulatory option(s). Our mission is to help our clients secure a successful market position by providing strategic scientific and regulatory support. Our customized strategies help minimize cost, reduce risk, and ensure success by assuring the safety, regulatory compliance, and benefit of our clients' products.

  • Food and Dietary Supplements
    • Generally Recognized As Safe (GRAS)
    • New Dietary Ingredient Notifications (NDIN)
    • New Dietary Ingredient Notifications (NDIN)
    • Food Additive Petitions
    • Novel Food Dossier and Notification
    • Health Claim and Structure/Function Claim Substantiation
    • U.S. Department of Agriculture (USDA) Petitions
    • Food Contact Substances Notification
    • Adverse Event Analysis
    • Publication Preparation
  • International Regulatory Support
    • Food Additive Petitions
      • Canada
      • European Union
      • Asia
      • Latin America
      • Africa
    • Novel Food Submission and Substantial Equivalence Notifications
      • Canada
      • European Union
    • Joint FAO/WHO Expert Committee on Food Additives (JECFA) Submissions
      • Staff Member Listed as Scientific Expert for 2011-2015
  • Consumer Products
    • Exposure both to known constituents and to unintentional contaminants from consumer products can be responsible for injuries, deaths, and property damage. Spherix Consulting provides strategic, scientific, and regulatory support for these products, including:
      • Regulatory Review
      • Safety Evaluation
      • Product Liability Assessment
  • Pharmaceuticals
    • Preparing and Reviewing Protocols for Pre-clinical Testing, Monitoring Tests, and Summarizing Results
    • Preparing and Reviewing Protocols for Clinical Trials and Summarizing Results
    • Assessing Health Risks to Humans From Contaminants or Excipients
    • Preparing Investigational New Drug (IND) and New Drug Applications (NDA)
    • Scientific Liaison With the U.S. Food and Drug Administration (FDA)
  • Industrial Chemicals and Pesticides
    • Antimicrobials
    • Biopesticides and conventional, including:
      • Bactericides
      • Baits
      • Fungicides
      • Genetically modified organisms (GMOs) or biological pesticides
      • Herbicides
      • Insecticides
      • Rodenticides and repellents
  • Exposure Assessment
    • Exposure Assessments Include:
      • Intake of Direct Food Additives, Novel Food Ingredients and Generally Recognized As Safe (GRAS) Substances
      • Nutrients from Various Food Sources
      • Leachate Residues from Food Contact Substances
      • Impurity or Contaminant Residues in Foods
    • Food Consumption Data Used in Exposure Assessments
      • United States:
        • National Health and Nutrition Examination Surveys (NHANES)
        • Food/Ingredient Per Capita Sales or Consumption Estimates
        • Total Diet Studies
      • European Union:
        • National Diet and Nutrition Survey (NDNS)
  • Animal and Pet Feed
    • Generally Recognized As Safe (GRAS) Determinations
    • Association of American Feed Control Officials (AAFCO) Submissions
  • Product Stewardship
    • Risk Assessment
    • Risk Management
    • Risk Communication
    • Supply Chain Assessments
  • Due Diligence Assessments
    • Assessment of Regulatory Filings
      • Investigational New Drug (IND) Applications
      • New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA)
      • Food and Drug Administration (FDA) 510(k) Clearances
      • FDA Pre-market Approvals
    • Supply Chain Assessments
    • Intellectual Property (IP), Product, and Business Acquisitions
      • Scientific Status and Risks
      • Regulatory Status and Risks
      • Intellectual Property Status and Risks
  • Medical Devices
    • Regulatory Filings (510(k), Investigational Device Exemption (IDE), Premarket Approval (PMA, Combination Products, Master Files)
    • Class I, II, and III Devices
    • Substantial Equivalence Determinations
    • Material Specifications, Standard Test Methods, and Standard Test Guides
    • Biocompatibility
    • Risk analysis: Efficacy and Performance Specifications
    • Clinical Trials
    • Quality Review and Design Review

Spherix Consulting Introductory Presentation (pdf)