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EAS Dietary Supplement Services

Dietary Supplements EAS is a leading provider of regulatory consulting services to the dietary supplement industry for adherence to the Dietary Supplement Health and Education Act (DSHEA). EAS offers the best in development of regulatory strategies and submissions assistance. We design clinical studies to substantiate claims made on dietary supplement labels and conducts scientific literature reviews in the preparation of petitions for FDA approvals of conventional and qualified health claims for dietary supplement ingredients. EAS will also prepare New Dietary Ingredient Notifications (NDINs) for FDA review as required in 21 CFR 190 and serve as the US Agent for foreign dietary supplement firms distributing product within the U.S. Choose EAS for:

  • Develop Regulatory Strategies
  • Structure/Function and Health Claims
  • GRAS Submissions
  • NDI Notifications
  • Dietary Supplement Labeling
    • Training and Reviews
  • Good Manufacturing Practice Training
  • Facility Auditing
    • Gap Analyses »» Mock-FDA Inspections »» Contractor Audits (Manufacturers, Packagers, Distributors and Laboratory)
  • Quality System Development
  • Standard Operating Procedure (SOP) Writing
  • Establishment of Specifications
    • »» Raw Material »» In-Process »» Finished Product
  • Stability Program Development
  • Quality Agreement Preparation
  • Regulatory Remediation
    • 483 Observation Response »» Warning Letter Response »» Consent Decrees »» Corrective and Preventative Action (CAPA) Plans and Implementation
  • Expert Witness
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