EAS Consulting Group, leaders in FDA regulatory consulting services, offers capabilities and comprehensive services to clients seeking to file a Generally Recognized as Safe (GRAS) and other submissions documenting food safety to the U.S. Food and Drug Administration (FDA).
As part of the safety documentation, companies seeking to petition FDA’s recognition of a new food ingredient must submit data proving the ingredient in review is safe when prepared and used under conditions commensurate with those of the sponsor or petitioning organization.
In some cases, previous publicly available studies may be utilized. But in others, new studies must be designed, a Contract Research Organization (CRO) must be identified, and the study must have strict oversight by a dedicated team of toxicologists and microbiologists who review protocols and study progress to ensure validation and verification.
EAS, with our over 150 independent consultants, experts in their fields, are pleased to provide services for those firms seeking to demonstrate food safety, both through GRAS or Independent Self-GRAS filing. Our experts help with developing study designs and protocols to properly and accurately demonstrate performance criteria, assist with the identification of an appropriate CRO, coordinate study initiation and management with the CRO as well as provide on-going monitoring of study protocols and outcomes. These expanded services are in addition to the GRAS and toxicology services for which EAS is well known, such as pre-meetings with FDA, performing initial feasibility studies, identification of appropriate data to support study reports and dossier preparation and submission.
Should your company be in the market research phase of a new or reformulated product that requires GRAS, including the development of a New Infant Formula, contact EAS Consulting Group to learn more about our services and how we may support your efforts. You may view GRAS information our website, review our GRAS services sheet or contact Cathryn Sacra directly at email@example.com or 571-447-5505.